Cleared Traditional

PENTAX FACE MASK (K933683) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933683 · Pentax Precision Instrument Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
673d
Days
Class 2
Risk

K933683 is an FDA 510(k) clearance for the PENTAX FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Orangeburg, US). The FDA issued a Cleared decision on June 2, 1995 after a review of 673 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K933683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date June 02, 1995
Days to Decision 673 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
544d slower than avg
Panel avg: 129d · This submission: 673d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 401
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K933683.
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
K964114 · Depuy, Inc. · May 1997
MEDLINE ADMISSION KITS
K965107 · Medline Industries, Inc. · Mar 1997
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
K955382 · 3M Company · May 1996
3M SURGICAL MASK WITH FACE SHEILD
K940707 · 3M Company · May 1994
SURGICAL APPAREL
K914832 · W.L. Gore & Associates, Inc. · Feb 1992
TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK
K910110 · 3M Company · Mar 1991