Cleared Traditional

STRATO(R) PCA INFUSER (K864808) - FDA 510(k) Clearance

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

K864808 · Strato Medical Corp. · General Hospital
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Jan 1987
Decision
43d
Days
Class 2
Risk

K864808 is an FDA 510(k) clearance for the STRATO(R) PCA INFUSER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Strato Medical Corp. (Beverly, US). The FDA issued a Cleared decision on January 21, 1987 after a review of 43 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 Strato Medical Corp. devices

Submission Details

510(k) Number K864808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date January 21, 1987
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 220
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K864808.
I.V. SET W/SINGLE-CHANNEL CASSETTE
K865059 · Abbott Laboratories · Feb 1987
I.V. SET WITH DUAL-CHANNEL CASSETTE
K865060 · Abbott Laboratories · Feb 1987
AMBULATORY INFUSION PUMP, MODEL AS30C
K863864 · Travenol Laboratories, S.A. · Feb 1987
BARD HARVARD MINI-INFUSER 950 PUMP
K864233 · C.R. Bard, Inc. · Jan 1987
ABBOTT LIFECARE(R) 4100 PCA INFUSER
K863997 · Abbott Laboratories · Dec 1986
BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP
K863683 · C.R. Bard, Inc. · Oct 1986