Cleared Traditional

K893417 - SURGIFRESH SUB-MICRON MASK NO. 901008-000

K893417 is an FDA 510(k) clearance for SURGIFRESH SUB-MICRON MASK NO. 901008-000, manufactured by Texas Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K893417 · Texas Medical Products, Inc. · General Hospital
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Jun 1989
Decision
51d
Days
Class 2
Risk

K893417 is an FDA 510(k) clearance for the SURGIFRESH SUB-MICRON MASK NO. 901008-000. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Texas Medical Products, Inc. (The Woodlands, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 51 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.

FDA 510(k) Submission Details - K893417

510(k) Number K893417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date June 22, 1989
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
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 606
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K893417.
FACE PROTECTION PAK(TM)
K894905 · Protech Products · Sep 1989
ISOLATION MASKS
K893939 · James River Corp. · Jul 1989
MODIFIED STERILIZATION OF TUR APRONS
K893634 · Brant-Wald Surgicals, Inc. · Jun 1989
SAFE-T-FACE DISPOSABLE FACE SHIELD
K892451 · Barry S. Smith Co. · May 1989
CARERITE FACE MASK
K891141 · Cost Rite Health Products, Inc. · Apr 1989
SURGICAL FACE MASK-EAR LOOP
K891051 · Dispomed, Inc. · Apr 1989
K893417 · SURGIFRESH SUB-MICRON MASK NO. 901008-000
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