Cleared Traditional

K900665 - DRESSING CHANGE KIT

K900665 is an FDA 510(k) clearance for DRESSING CHANGE KIT, manufactured by Healthdyne Cardiovascular, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K900665 · Healthdyne Cardiovascular, Inc. · General Hospital
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May 1990
Decision
90d
Days
Class 2
Risk

K900665 is an FDA 510(k) clearance for the DRESSING CHANGE KIT. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Healthdyne Cardiovascular, Inc. (Irvine, US). The FDA issued a Cleared decision on May 14, 1990 after a review of 90 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 Healthdyne Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K900665

510(k) Number K900665 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 13, 1990
Decision Date May 14, 1990
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 453
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K900665.
3M BRAND EAR LOOP FACE MASK, 2000F
K910182 · 3M Company · Mar 1991
THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK
K902546 · Anago, Inc. · Sep 1990
THE PROTECTOR II, LASER SURGICAL MASK
K902547 · Anago, Inc. · Sep 1990
TECNOL LAZER(TM) SURGICAL MASK
K896193 · Tecnol New Jersey Wound Care, Inc. · Feb 1990
SURGIFRESH SUB-MICRON MASK NO. 901008-000
K893417 · Texas Medical Products, Inc. · Jun 1989
ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
K890771 · 3M Company · Mar 1989