FDA 510(k) Pathway — Patent Pending

Pressurize IV Bags in Seconds,
Not Minutes

Rapid Bolus is a CO₂-powered handheld device that pressurizes IV pressure bags to 300 mmHg in under 5 seconds — replacing 30–60 seconds of manual hand-bulb inflation during massive hemorrhage resuscitation.

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12×
Faster Than Manual
<5s
To 300 mmHg
3-Layer
Safety Architecture
$200
Single-Use Device
Every Second Counts in Hemorrhagic Shock
Current Standard
  • Manual hand-bulb inflation takes 30–60 seconds of sustained squeezing per bag
  • Requires two-handed operation, preventing simultaneous patient care
  • Powered systems cost $25,000–$40,000 and require wall power
  • Operator fatigue during multi-bag resuscitation introduces variability
Rapid Bolus
  • CO₂-powered pressurization reaches 300 mmHg in under 5 seconds
  • One-handed operation — maintain hemorrhage control with the other
  • No power source, no maintenance — works anywhere, every time
  • Consistent target pressure eliminates operator-dependent variability
Engineered for the Most Critical Moments
Eight model variants spanning single-use mechanical to electronic reloadable with automated pump control — all built on a common multi-layer safety architecture.

3-Layer Passive Safety

Flow restrictor, pressure relief valve, and downstream pressure-actuated shut-off valve prevent overpressurization — even with single-component failure.

Sub-5 Second Pressurization

Reach therapeutic 300 mmHg in approximately 3–5 seconds. Compatible with crystalloids, blood products, and irrigation fluids.

One-Handed Operation

Pistol-grip form factor enables single-handed actuation while the clinician maintains hemorrhage control or performs other tasks.

No External Power

Self-contained CO₂ cartridge. No batteries, no wall power, no compressed air lines. Ideal for austere, pre-hospital, and military environments.

Universal Compatibility

Standard Luer-lock connection interfaces with existing IV pressure bags, tubing sets, and clinical workflows — no new infrastructure required.

Model Family

From the MS single-use disposable to the ER-SP electronic reloadable with automated pump — a device optimized for every clinical setting.

Serving Every Point of Critical Care

Rapid Bolus addresses a universal clinical need across the continuum of care — from pre-hospital trauma and emergency departments to operating rooms, intensive care units, and military field medicine.

Modern massive transfusion protocols employ 1:1:1:1 ratios of packed red blood cells, fresh frozen plasma, platelets, and cryoprecipitate. Each of these blood components requires pressure infusion, significantly expanding the addressable device consumption per critical case.

Emergency Departments Operating Rooms Trauma Centers ICU EMS / Pre-Hospital Military / Austere High-Risk Obstetrics Catheterization Labs
U.S. Total Addressable Market
$137M+
Annual recurring opportunity
Cost Avoidance per Case
170:1
to 315:1 ROI vs. device cost
Clear Path to Market

Provisional Patent Filed

Comprehensive coverage of all eight model variants, multi-layer safety architecture, and atmospheric reference spool valve IP.

FDA 510(k) Pathway

Class II submission with verified predicate device (K974074, ZOLL Power Infuser). Voluntary clearance to strengthen market position.

Design Validation

Active component testing with precision valve manufacturer. Custom pressure relief valve development in progress.

Commercial Launch Target

30-month timeline from funding to first commercial sales, following FDA clearance and pilot manufacturing.

Intellectual Property

Our provisional patent filing provides comprehensive coverage across all device configurations — from mechanical single-use to electronic reloadable with automated pump control. Broad functional claims protect the core innovation while dependent claims cover specific embodiments.

A separate provisional application covers our atmospheric reference spool valve technology, which represents standalone licensable IP independent of the primary device.

Patent Pending — Trademark Filed
Ready to Learn More?

We welcome inquiries from investors, potential strategic partners, and healthcare professionals interested in the Rapid Bolus platform.

info@rapidbolus.com