Cleared Traditional

K915499 - FLO-GARD 8000 HALF-SET

K915499 is the FDA 510(k) clearance for FLO-GARD 8000 HALF-SET by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K915499 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
88d
Days
Class 2
Risk

K915499 is an FDA 510(k) clearance for the FLO-GARD 8000 HALF-SET. 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 March 6, 1992 after a review of 88 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 K915499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1991
Decision Date March 06, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
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 444
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K915499.
AVI MODEL 3000 INFUSION PUMP
K920588 · 3M Health Care, Ltd. · Apr 1992
AVI MODEL 275CI INFUSION PUMP
K920680 · 3M Health Care, Ltd. · Apr 1992
AVI MODEL 285CI INFUSION PUMP
K920681 · 3M Health Care, Ltd. · Apr 1992
PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF
K913931 · Abbott Laboratories · Mar 1992
FLO-GARD(R) 6201
K915522 · Baxter Healthcare Corp · Feb 1992
FLO-GARD(R) 6301
K915523 · Baxter Healthcare Corp · Feb 1992