Cleared Traditional

K883614 - CYTOGUARD(R)

K883614 is an FDA 510(k) clearance for CYTOGUARD, manufactured by Survival Technology, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K883614 · Survival Technology, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
22d
Days
Class 2
Risk

K883614 is an FDA 510(k) clearance for the CYTOGUARD(R). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Survival Technology, Inc. (Bethesda, US). The FDA issued a Cleared decision on September 15, 1988 after a review of 22 days - a notably fast clearance cycle.

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: 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 Survival Technology, Inc. devices

FDA 510(k) Submission Details - K883614

510(k) Number K883614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1988
Decision Date September 15, 1988
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
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 536
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K883614.
CONTROL SYRINGE
K884497 · Professional Medical Services · Dec 1988
SINGLE-FIL(TM) SYRINGE
K883955 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
MANAN HUBER STYLE INFUSION NEEDLE
K883744 · Manan Medical Products, Inc. · Sep 1988
OPHTHALMIC PAO VALVE
K882536 · Look, Inc. · Sep 1988
BD MICROFINE IV PEN INJECTOR
K881775 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1988
MX350 (SERIES) CONTROL SYRINGE
K883094 · Medex, Inc. · Aug 1988