Cleared Traditional

K955382 - 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95

K955382 is an FDA 510(k) clearance for 3M MODEL 1860 HEALTH CARE PARTICULATE R..., manufactured by 3M Company. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K955382 · 3M Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
159d
Days
Class 2
Risk

K955382 is an FDA 510(k) clearance for the 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on May 1, 1996 after a review of 159 days - an extended review 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: 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 3M Company devices

FDA 510(k) Submission Details - K955382

510(k) Number K955382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1995
Decision Date May 01, 1996
Days to Decision 159 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
30d slower than avg
Panel avg: 129d · This submission: 159d
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 505
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K955382.
BODILY FLUID DISPOSAL KIT
K961217 · Transidyne General Corp. · Jul 1996
EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS
K960048 · Safetec of America, Inc. · Jul 1996
STS SHIELD WITH MASK
K961402 · Innovative Outsourcing Solutions · Jul 1996
FLUID RESISTANT MASK
K955556 · American Threshold Healthcare · Apr 1996
FLUID REISISTANT EYESHIELD MASK
K955557 · American Threshold Healthcare · Apr 1996
SURGICAL MASK (NON-STERILE)
K955513 · United Medical Ent., Inc. · Apr 1996