Cleared Traditional

K802406 - CYTOTRAN I BONE MARROW ASPIRATION SYSTEM

K802406 is an FDA 510(k) clearance for CYTOTRAN I BONE MARROW ASPIRATION SYSTEM, manufactured by Applied Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K802406 · Applied Medical Devices, Inc. · General Hospital
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Jan 1981
Decision
104d
Days
Class 2
Risk

K802406 is an FDA 510(k) clearance for the CYTOTRAN I BONE MARROW ASPIRATION SYSTEM. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Applied Medical Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 15, 1981 after a review of 104 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Medical Devices, Inc. devices

FDA 510(k) Submission Details - K802406

510(k) Number K802406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1980
Decision Date January 15, 1981
Days to Decision 104 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 129d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 317
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K802406.
PREFILLED PULSATOR SYRINGE
K811009 · Concord Laboratories, Inc. · Jun 1981
PREFILLED PULSATOR SYRINGE
K810995 · Concord Laboratories, Inc. · May 1981
PISTON SYRINGE
K811065 · Sherwood Medical Co. · May 1981
CONTROL SYRINGE
K801430 · Abco Dealers, Inc. · Jul 1980
BURRON MULTI-AD SYRINGE CAP
K801311 · Burron Medical Products, Inc. · Jun 1980
DYNACOR STERILE BLOOD GAS SPECIMEN TRAY
K792033 · Medline Industries, Inc. · Nov 1979