Cleared Traditional

K993972 - DISPOSABLE INFUSION PUMP KIT

K993972 is the FDA 510(k) clearance for DISPOSABLE INFUSION PUMP KIT by Biomet, Inc.. It is a Class 2 General Hospital device (product code MEB) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K993972 · Biomet, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
76d
Days
Class 2
Risk

K993972 is an FDA 510(k) clearance for the DISPOSABLE INFUSION PUMP KIT. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 7, 2000 after a review of 76 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 Biomet, Inc. devices

Submission Details

510(k) Number K993972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1999
Decision Date February 07, 2000
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEB Pump, Infusion, Elastomeric
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 - MEB Pump, Infusion, Elastomeric

All 32
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K993972.
I-FLOW ELASTOMERIC PUMP
K020862 · I-Flow Corp. · Mar 2002
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
K020660 · I-Flow Corp. · Mar 2002
MULTIRATE INFUSOR SV
K011317 · Baxter Healthcare Corp · Jun 2001
INTRAOP CATHETER
K991543 · I-Flow Corp. · Oct 1999
NERVE BLOCK INFUSION KIT
K984502 · I-Flow Corp. · Mar 1999
PAINBUSTER INFUSION KIT
K982946 · I-Flow Corp. · Nov 1998