Cleared Traditional

K902547 - THE PROTECTOR II

K902547 is an FDA 510(k) clearance for THE PROTECTOR II, manufactured by Anago, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K902547 · Anago, Inc. · General Hospital
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Sep 1990
Decision
89d
Days
Class 2
Risk

K902547 is an FDA 510(k) clearance for the THE PROTECTOR II, LASER SURGICAL MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on September 5, 1990 after a review of 89 days - a notably fast clearance cycle.

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: 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 Anago, Inc. devices

FDA 510(k) Submission Details - K902547

510(k) Number K902547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1990
Decision Date September 05, 1990
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 440
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K902547.
SURGICAL FACE MASK
K905749 · Anago, Inc. · Mar 1991
3M BRAND EAR LOOP FACE MASK, 2000F
K910182 · 3M Company · Mar 1991
THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK
K902546 · 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