Cleared Traditional

K921461 - TURKEL THORACENTESIS NEEDLE

K921461 is an FDA 510(k) clearance for TURKEL THORACENTESIS NEEDLE, manufactured by Symbiosis Corp.. The device is a Class 2 Microbiology device with product code GSS cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K921461 · Symbiosis Corp. · Microbiology device
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Jul 1992
Decision
125d
Days
Class 2
Risk

K921461 is an FDA 510(k) clearance for the TURKEL THORACENTESIS NEEDLE. Classified as Antisera, Fluorescent, Pseudomonas Aeruginosa (product code GSS), Class II - Special Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on July 30, 1992 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3415 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Symbiosis Corp. devices

FDA 510(k) Submission Details - K921461

510(k) Number K921461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1992
Decision Date July 30, 1992
Days to Decision 125 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 102d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GSS Device Classification - Class 2, Special Controls

Product Code GSS Antisera, Fluorescent, Pseudomonas Aeruginosa
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3415
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 Microbiology devices follow this clearance model.