Cleared Traditional

K891237 - MODEL 600 SYRINGE PUMP

K891237 is the FDA 510(k) clearance for MODEL 600 SYRINGE PUMP by 3M Company. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K891237 · 3M Company · General Hospital
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Dec 1989
Decision
274d
Days
Class 2
Risk

K891237 is an FDA 510(k) clearance for the MODEL 600 SYRINGE PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on December 6, 1989 after a review of 274 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.

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Submission Details

510(k) Number K891237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1989
Decision Date December 06, 1989
Days to Decision 274 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 129d · This submission: 274d
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 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K891237.
OHMEDA 9000 SYRINGE PUMP
K896023 · Ohmeda Medical · Jan 1990
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE
K895797 · Imed Corp. · Jan 1990
BECTON DICKINSON RATE INFUSER II SYSTEM
K896593 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
BARD LIBERATOR DISPOSABLE INFUSION SYSTEM
K894292 · C.R. Bard, Inc. · Nov 1989
MODEL 285 INFUSION PUMP
K894321 · 3M Company · Oct 1989
MODEL 480 INFUSION PUMP
K894320 · 3M Company · Oct 1989