Cleared Traditional

PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM (K911782) - FDA 510(k) Clearance

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

K911782 · Strato Medical Corp. · General Hospital
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Nov 1991
Decision
214d
Days
Class 2
Risk

K911782 is an FDA 510(k) clearance for the PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM. 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 November 22, 1991 after a review of 214 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Strato Medical Corp. devices

Submission Details

510(k) Number K911782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1991
Decision Date November 22, 1991
Days to Decision 214 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 129d · This submission: 214d
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 K911782.
FLO-GARD(R) 6201
K915522 · Baxter Healthcare Corp · Feb 1992
FLO-GARD(R) 6301
K915523 · Baxter Healthcare Corp · Feb 1992
PROVIDER APM INFUSION PUMP
K914349 · Abbott Laboratories · Dec 1991
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
K913718 · Abbott Laboratories · Oct 1991
PANCRETEC I.V. MODEL 5500 INFUSER
K913719 · Abbott Laboratories · Oct 1991
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
K913720 · Abbott Laboratories · Oct 1991