Cleared Traditional

MANAN SELDINGER NEEDLE (K851833) - FDA 510(k) Clearance

Class I Cardiovascular device.

K851833 · Manan Manufacturing Co., Inc. · Cardiovascular device
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Jul 1985
Decision
76d
Days
Class 1
Risk

K851833 is an FDA 510(k) clearance for the MANAN SELDINGER NEEDLE. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Manan Manufacturing Co., Inc. (Skokie, US). The FDA issued a Cleared decision on July 11, 1985 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device oversight 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 Manan Manufacturing Co., Inc. devices

Submission Details

510(k) Number K851833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date July 11, 1985
Days to Decision 76 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DWS Instruments, Surgical, Cardiovascular

All 7
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K851833.
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DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · Howmedica Corp. · Mar 1982
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · Howmedica Corp. · Sep 1980
AORTIC PUMP
K780567 · Ethicon, Inc. · Apr 1978