Cleared Traditional

K851833 - MANAN SELDINGER NEEDLE

K851833 is an FDA 510(k) clearance for MANAN SELDINGER NEEDLE, manufactured by Manan Manufacturing Co., Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 76-day FDA review.

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

FDA 510(k) Submission Details - K851833

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.

DWS Device Classification - Class 1, General Controls

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 40
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K851833.
PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)
K881717 · Buckman Co., Inc. · Jul 1988
MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY
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VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET
K861745 · Keeler Instruments, Inc. · May 1986
TELEFLEX MEDICAL INTRODUCER NEEDLE
K851140 · Teleflexmedical, Inc. · Jun 1985
GORE-TEX TUNNELER
K844584 · W.L. Gore & Associates, Inc. · Jan 1985
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
K840305 · Imm Enterprises , Ltd. · Apr 1984