Cleared Traditional

FLO-GARD 6300 BLOOD PUMPING INDICATION (K900699) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900699 · Baxter Healthcare Corp · General Hospital
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Apr 1990
Decision
56d
Days
Class 2
Risk

K900699 is an FDA 510(k) clearance for the FLO-GARD 6300 BLOOD PUMPING INDICATION. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on April 10, 1990 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K900699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1990
Decision Date April 10, 1990
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 219
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K900699.
RATE INFUSER PLUS
K900742 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990
LIFECARE MICRO PUMP (INFUSION PUMP)
K893769 · Abbott Laboratories · Jun 1990
PANCRETEC I.V. MODEL 5000 INFUSER
K895867 · Abbott Laboratories · Jun 1990
AVI MODEL 840 DUAL CHANNEL INFUSION PUMP
K900204 · 3M Company · Apr 1990
LIFECARE(R) 175 INFUSER
K900057 · Abbott Laboratories · Mar 1990
AVI MICRO 210CM INFUSION PUMP
K897013 · 3M Company · Mar 1990