# K970448: PCM 2000; Isolair Apr Model 2735

- Pathway: 510(k) (Traditional)
- Applicant: Tecnol Medical Products, Inc.
- Decided: Apr 30, 1997 after 83 days
- Product code: MSH (Respirator, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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

## Indications for use
Meets the CDC guidelines for TB exposure control. Has a filter efficiency level of 95% against solid particulate aerosols free of oil (Type N95 respirator). Designed to be fluid resistant to splash and spatter of blood and body fluids.

Source page: https://510kreport.com/device/K970448
Methodology: https://510kreport.com/methodology