Cleared Traditional

K833438 - PREPACELL-STERILE-BONE MARROW ASPIR

K833438 is an FDA 510(k) clearance for PREPACELL-STERILE-BONE MARROW ASPIR, manufactured by Applied Medical Devices, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K833438 · Applied Medical Devices, Inc. · General & Plastic Surgery device
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Feb 1984
Decision
127d
Days
Class 1
Risk

K833438 is an FDA 510(k) clearance for the PREPACELL-STERILE-BONE MARROW ASPIR. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Applied Medical Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 9, 1984 after a review of 127 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 Applied Medical Devices, Inc. devices

FDA 510(k) Submission Details - K833438

510(k) Number K833438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date February 09, 1984
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

KDD Device Classification - Class 1, General Controls

Product Code KDD Kit, Surgical Instrument, 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 - KDD Kit, Surgical Instrument, Disposable

All 20
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K833438.
ENTERON ABDOMINAL PARACENTESIS TRAY
K874063 · Endovations · Dec 1987
C-SECTION TRAY
K842627 · Deroyal Industries, Inc. · Sep 1984
STERILE SUTURE BOOTS
K834135 · Devon Industries, Inc. · Apr 1984
FIRST AID KITS
K831795 · I M, Inc. · Sep 1983
ACKRAD INCISION & DRAIN SET
K813103 · Ackrad Laboratories · Dec 1981
LARGE WOUND DRESSING KIT
K803119 · American Medical Disposable, Inc. · Dec 1980