Cleared Traditional

K961217 - BODILY FLUID DISPOSAL KIT

K961217 is an FDA 510(k) clearance for BODILY FLUID DISPOSAL KIT, manufactured by Transidyne General Corp.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K961217 · Transidyne General Corp. · General Hospital
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Jul 1996
Decision
119d
Days
Class 2
Risk

K961217 is an FDA 510(k) clearance for the BODILY FLUID DISPOSAL KIT. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on July 25, 1996 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Transidyne General Corp. devices

FDA 510(k) Submission Details - K961217

510(k) Number K961217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1996
Decision Date July 25, 1996
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 - FXX Mask, Surgical

All 500
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K961217.
COMPLEAT SURGICAL MASK
K962654 · Carl Parker Associates, Inc. · Jan 1997
N95 FILTERING FACEPIECE
K962443 · Survivair, Inc. · Jan 1997
2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD
K962286 · Berkley Medical Resources, Inc. · Oct 1996
EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS
K960048 · Safetec of America, Inc. · Jul 1996
STS SHIELD WITH MASK
K961402 · Innovative Outsourcing Solutions · Jul 1996
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
K955382 · 3M Company · May 1996