Cleared Special

K081633 - PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS

K081633 is an FDA 510(k) clearance for PRIMAGARD 80, manufactured by Primed Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Special 510(k) pathway after a 61-day FDA review.

K081633 · Primed Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
61d
Days
Class 2
Risk

K081633 is an FDA 510(k) clearance for the PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Primed Medical Products, Inc. (Edmonton, Alberta, CA). The FDA issued a Cleared decision on August 11, 2008 after a review of 61 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Primed Medical Products, Inc. devices

FDA 510(k) Submission Details - K081633

510(k) Number K081633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2008
Decision Date August 11, 2008
Days to Decision 61 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 129d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

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 525
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K081633.
TIDI FACEMASK
K092580 · Tidi Products,Llc · Feb 2010
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
K092012 · Primed Medical Products, Inc. · Sep 2009
CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR
K082258 · Crosstex International · Oct 2008
DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE
K070407 · Dukal Corp. · Mar 2007
SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
K063043 · Modern Healthcare Corp. · Mar 2007
DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530
K061864 · Dukal Corp. · Sep 2006