Cleared Traditional

K874894 - TECNOL LASER SURGICAL MASK

K874894 is an FDA 510(k) clearance for TECNOL LASER SURGICAL MASK, manufactured by Tecnol New Jersey Wound Care, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K874894 · Tecnol New Jersey Wound Care, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
118d
Days
Class 2
Risk

K874894 is an FDA 510(k) clearance for the TECNOL LASER SURGICAL MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Fort Worth, US). The FDA issued a Cleared decision on March 28, 1988 after a review of 118 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 Tecnol New Jersey Wound Care, Inc. devices

FDA 510(k) Submission Details - K874894

510(k) Number K874894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1987
Decision Date March 28, 1988
Days to Decision 118 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 129d · This submission: 118d
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 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K874894.
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
ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK
K881618 · 3M Company · May 1988
GUARDALL SHIELD
K875008 · Anago, Inc. · Mar 1988
TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD
K880757 · Tecnol New Jersey Wound Care, Inc. · Mar 1988
KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001
K875194 · Welch Allyn, Inc. · Jan 1988