Cleared Traditional

K971130 - DEFEND FLUID RESISTANT PLEATED MASK

K971130 is an FDA 510(k) clearance for DEFEND FLUID RESISTANT PLEATED MASK, manufactured by Carl Parker Associates, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K971130 · Carl Parker Associates, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
92d
Days
Class 2
Risk

K971130 is an FDA 510(k) clearance for the DEFEND FLUID RESISTANT PLEATED MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Carl Parker Associates, Inc. (Bethesda, US). The FDA issued a Cleared decision on June 27, 1997 after a review of 92 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 Carl Parker Associates, Inc. devices

FDA 510(k) Submission Details - K971130

510(k) Number K971130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1997
Decision Date June 27, 1997
Days to Decision 92 days
Submission Type Traditional
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
37d faster than avg
Panel avg: 129d · This submission: 92d
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 464
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K971130.
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
K972883 · Cypress Medical Products, Ltd. · Feb 1998
FACE MASK, SURGICAL MASK, NON-STERILE
K970835 · Tucker & Associates · Sep 1997
FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)
K971744 · Berkley Medical Resources, Inc. · Jul 1997
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
K964114 · Depuy, Inc. · May 1997
EKONIC DENTAL/MEDICAL MASK (MD 610)
K970440 · Ekonic Company, Ltd. · Mar 1997
MEDLINE ADMISSION KITS
K965107 · Medline Industries, Inc. · Mar 1997