Cleared Traditional

HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE) (K896546) - FDA 510(k) Clearance

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

K896546 · Block Medical, Inc. · General Hospital
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Feb 1990
Decision
81d
Days
Class 2
Risk

K896546 is an FDA 510(k) clearance for the HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Block Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on February 6, 1990 after a review of 81 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 Block Medical, Inc. devices

Submission Details

510(k) Number K896546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1989
Decision Date February 06, 1990
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
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 232
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K896546.
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
FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP
K891289 · Baxter Healthcare Corp · Feb 1990
BECTON DICKINSON RATE INFUSER II SYSTEM
K896593 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
MODEL 600 SYRINGE PUMP
K891237 · 3M Company · Dec 1989