Cleared Traditional

K800412 - ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW

K800412 is an FDA 510(k) clearance for ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW, manufactured by A.D.T. Lab Industries. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K800412 · A.D.T. Lab Industries · General & Plastic Surgery device
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Apr 1980
Decision
62d
Days
Class 1
Risk

K800412 is an FDA 510(k) clearance for the ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by A.D.T. Lab Industries (Mchenry, US). The FDA issued a Cleared decision on April 28, 1980 after a review of 62 days - a notably fast clearance cycle.

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: 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 A.D.T. Lab Industries devices

FDA 510(k) Submission Details - K800412

510(k) Number K800412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1980
Decision Date April 28, 1980
Days to Decision 62 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 115d · This submission: 62d
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 K800412.
ADT BONE MARROW BIOPSY ASPIRATION TRAY
K800409 · A.D.T. Lab Industries · Apr 1980
ADT BONE MARROW BIOPSY-ASPIRATION TRAY
K800410 · A.D.T. Lab Industries · Apr 1980
ASPIRATION TRAY W/FERRIS DISP. ILLINOIS
K800411 · A.D.T. Lab Industries · Apr 1980
ADT SOFT TISSUE BIOPSY TRAY
K800414 · A.D.T. Lab Industries · Apr 1980
ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL
K800417 · A.D.T. Lab Industries · Apr 1980
FERRIS MODIFIED DISP. IL STERNAL-ILIAC
K800413 · A.D.T. Lab Industries · Mar 1980