# K974068: PFR95 Particulate Filter Respirator and Surgical Mask Regular Size, PFR95 Particulate Filter Respirator and Surgical

- Pathway: 510(k) (Traditional)
- Applicant: Tecnol Medical Products, Inc.
- Decided: Dec 22, 1997 after 55 days
- Product code: MSH (Respirator, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Gerson Isolair APR Type N95 Model 2735 Respirator and Surgical Mask: named in the summary without a submission number

## Most influential descendants
- K102092: Pro Gear N95 Particulate Filter Respirator & Surgical Mask, Regular Size  Model RP Ceries (2010), 2 descendants of its own
- K160271: N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 (2016), 1 descendant of its own
- K233022: Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small (2024), 0 descendants of its own
- K172963: Master-Frank N95 Particulate Respirator (2018), 0 descendants of its own

## Recalls of this device
- Aug 9, 2023 · Class II · Z-2626-2023: One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.

## Indications for use
The PFR95™ Particulate Filter Respirator and Surgical Masks are intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

Source page: https://510kreport.com/device/K974068
Methodology: https://510kreport.com/methodology