510(k) · Cleared

Cleared

Compleat Surgical Mask

K962654510(k) TraditionalCleared Jan 27, 1997203-day reviewClass II21 CFR 878.4040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Carl Parker Associates, Inc. · FXX Mask, Surgical

Cleared on Jan 27, 1997 as substantially equivalent to K830890 (Busse Hospital Disposables, Inc., 1983) and 2 other predicates after a 203-day review. Its family tree reaches back 1 generation to 1983.

Decided: Jan 27, 1997
Review: 203 days
Class: Class II
Product code: FXX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K830890 (1983). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK830890 Surgical Face MaskBusse Hospital Disposables, Inc. · 1983
This deviceK962654 Compleat Surgical MaskCarl Parker Associates, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K830890	Surgical Face Mask	Busse Hospital Disposables, Inc.	1983	—
0 (this device)	K962654	Compleat Surgical Mask	Carl Parker Associates, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0

FIG. 1 — Lineage of K962654, 1983–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FXX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FXX device

#1 K201479 DemeMASKscore 40.2 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K830890	Surgical Face Mask Summary page 2 …: 510(k) process The Conpleat Surgical Mask is substantially equivalent to (for example) the following devices Softwear. Fluid Resistant Masks, Busse Hosp Disposables, K-830890, Fluid Sheld Procedure Mask, Technol Inc., K-9321375, Fluid Resistant Mask, Mid America Medical, In¢c., K-934974. End of Summary…	Busse Hospital Disposables, Inc.	1983	—
*	K932137	Fluidshield Surgical/Procedure Mask/M. with Visor Summary page 2 …antially equivalent to (for example) the following devices Softwear. Fluid Resistant Masks, Busse Hosp Disposables, K-830890, Fluid Sheld Procedure Mask, Technol Inc., K-9321375, Fluid Resistant Mask, Mid America Medical, In¢c., K-934974. End of Summary Repl. p. 8a	Tecnol Medical Products, Inc.	1994	—
*	K934974	Fluid Resistant Mask with Wrap Around Eye Shield Summary page 2 …ftwear. Fluid Resistant Masks, Busse Hosp Disposables, K-830890, Fluid Sheld Procedure Mask, Technol Inc., K-9321375, Fluid Resistant Mask, Mid America Medical, In¢c., K-934974. End of Summary Repl. p. 8a	Mid America Medical, Inc.	1994	—
*	—	Softwear Fluid Resistant Masks Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.

How does its category compare?

All FXX devices

FXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FXX

6in 2025

2007high 218 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FXX

123in 2025

2007high 298 (2015) · low 113 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FXX

2in 2024

2007high 2 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FXX

11in 2025

2007high 67 (2021) · low 3 (2009)2025

MAUDE reports naming product code FXX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	11
2008	2	—	0	10
2009	1	—	0	3
2010	7	144	0	9
2011	6	137	0	8
2012	1	—	0	22
2013	3	219	0	9
2014	1	—	0	5
2015	5	298	0	14
2016	5	268	0	16
2017	1	—	0	45
2018	3	119	0	21
2019	4	124	2	23
2020	27	113	0	60
2021	218	162	0	67
2022	91	113	0	21
2023	22	139	1	21
2024	15	263	2	21
2025	6	123	0	11
2026	5	142	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K962654 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962654: Compleat Surgical Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962654

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026