Cleared Traditional

K923066 - FLO-GARD 2100 - 2M8281M

K923066 is an FDA 510(k) clearance for FLO-GARD 2100 - 2M8281M, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K923066 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
322d
Days
Class 2
Risk

K923066 is an FDA 510(k) clearance for the FLO-GARD 2100 - 2M8281M. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on May 13, 1993 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K923066

510(k) Number K923066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1992
Decision Date May 13, 1993
Days to Decision 322 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
193d slower than avg
Panel avg: 129d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZH Device Classification - Class 2, Special Controls

Product Code LZH Pump, Infusion, Enteral
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 - LZH Pump, Infusion, Enteral

All 20
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K923066.
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K945964 · Sherwood Medical Co. · Mar 1995
SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION
K940555 · Sandoz Nutrition · Feb 1995
SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP
K940556 · Sandoz Nutrition · Nov 1994
FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
K913958 · Abbott Laboratories · Feb 1992
KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE
K913413 · Sherwood Medical Co. · Nov 1991
COMPAT ENTERAL FEED PUMP 199235 & 199240
K891575 · Sandoz Nutrition · Sep 1989