Cleared Traditional

FLO-GARD(R) 6200, 6300 & 8000 (K913895) - FDA 510(k) Clearance

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

K913895 · Baxter Healthcare Corp · General Hospital
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Oct 1991
Decision
52d
Days
Class 2
Risk

K913895 is an FDA 510(k) clearance for the FLO-GARD(R) 6200, 6300 & 8000. 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 October 21, 1991 after a review of 52 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 K913895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1991
Decision Date October 21, 1991
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 129d · This submission: 52d
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 K913895.
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
K913718 · Abbott Laboratories · Oct 1991
PANCRETEC I.V. MODEL 5500 INFUSER
K913719 · Abbott Laboratories · Oct 1991
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
K913720 · Abbott Laboratories · Oct 1991
LIFECARE 4100 PCA INFUSER PLUS II
K912928 · Abbott Laboratories · Aug 1991
MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM
K911964 · Abbott Laboratories · Aug 1991
MODIFIED LIFECARE MODEL 175 INFUSER
K912092 · Abbott Laboratories · Aug 1991