# K962654: Compleat Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Carl Parker Associates, Inc.
- Decided: Jan 27, 1997 after 203 days
- Product code: FXX (Mask, 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
Longest line of descent: 1 generation back to K830890 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830890: Surgical Face Mask, Busse Hospital Disposables, Inc. (1983) Summary page 2.
- K932137: Fluidshield Surgical/Procedure Mask/M. with Visor, Tecnol Medical Products, Inc. (1994) Summary page 2.
- K934974: Fluid Resistant Mask with Wrap Around Eye Shield, Mid America Medical, Inc. (1994) Summary page 2.
- (no number) Softwear Fluid Resistant Masks: named in the summary without a submission number

## Indications for use
These products have the same intended use, to act as physical barrier including fluid-resistant properties, provide only very low impediment to breathing, avoid fogging of surgeons glasses, effective filtration of particles, droplets, not hinder speech.

Source page: https://510kreport.com/device/K962654
Methodology: https://510kreport.com/methodology