Cleared Traditional

K964722 - DELTA N95 RESPIRATOR

K964722 is an FDA 510(k) clearance for DELTA N95 RESPIRATOR, manufactured by Racal Filter Technologies, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K964722 · Racal Filter Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
74d
Days
Class 2
Risk

K964722 is an FDA 510(k) clearance for the DELTA N95 RESPIRATOR. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Racal Filter Technologies, Inc. (Brockville, Ontario, CA). The FDA issued a Cleared decision on February 7, 1997 after a review of 74 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 Racal Filter Technologies, Inc. devices

FDA 510(k) Submission Details - K964722

510(k) Number K964722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1996
Decision Date February 07, 1997
Days to Decision 74 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
55d faster than avg
Panel avg: 129d · This submission: 74d
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 K964722.
3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE
K965043 · Minnesota Mining and Mfg. Co. · Mar 1997
PROCEDURE SPECIFIC KITS
K964168 · Sage Products, Inc. · Mar 1997
AMSEAL SURGICAL FACE MASK
K964358 · American Seal Co. · Feb 1997
RACAL N95 RESIRATOR
K964723 · Racal Filter Technologies, Inc. · Feb 1997
BODILY FLUID DISPOSAL KIT
K961217 · Transidyne General Corp. · Jul 1996
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
K955382 · 3M Company · May 1996