Cleared Traditional

K912074 - BONE MARROW BIOPSY TRAY

K912074 is an FDA 510(k) clearance for BONE MARROW BIOPSY TRAY, manufactured by Manan Medical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K912074 · Manan Medical Products, Inc. · General & Plastic Surgery device
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Aug 1991
Decision
110d
Days
Class 1
Risk

K912074 is an FDA 510(k) clearance for the BONE MARROW BIOPSY TRAY. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on August 28, 1991 after a review of 110 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Manan Medical Products, Inc. devices

FDA 510(k) Submission Details - K912074

510(k) Number K912074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1991
Decision Date August 28, 1991
Days to Decision 110 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 115d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

Product Code GAA Needle, Aspiration And Injection, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GAA Needle, Aspiration And Injection, Disposable

All 72
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K912074.
KOPAN'S TARGET
K915417 · Medical Device Technologies, Inc. · Jan 1992
BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120
K914608 · Dlp, Inc. · Jan 1992
ASPIRATION/INJECTION NEEDLE
K913992 · Northgate Technologies, Inc. · Oct 1991
SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES
K910036 · Surgical Technologies, Inc. · Apr 1991
SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE
K901438 · Telemed Systems, Inc. · May 1990
WILSON-COOK LUNG BIOPSY NEEDLE
K897050 · Wilson-Cook Medical, Inc. · Apr 1990