510(k) · Cleared

Cleared

3M 1830 Fluid Block Anti-Fog Tie-on Surgical Mask and 3M 1830FS Fluid Block Anti-Fog Tie-on Surgical Mask with Face Shie

K965043510(k) TraditionalCleared Mar 10, 199783-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

Minnesota Mining and Mfg. Co. · FXX Mask, Surgical

Cleared on Mar 10, 1997 as substantially equivalent to K940707 (3M Company, 1994) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1991.

Decided: Mar 10, 1997
Review: 83 days
Class: Class II
Product code: FXX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K913043 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK913043 Modification Tecnol Fluidshield Surgical MasksTecnol New Jersey Wound Care, Inc. · 1991
This deviceK965043 3M 1830 Fluid Block Anti-Fog Tie-on Surgical Mask and 3M 1830FS…Minnesota Mining and Mfg. Co. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913043	Modification Tecnol Fluidshield Surgical Masks	Tecnol New Jersey Wound Care, Inc.	1991	—
0 (this device)	K965043	3M 1830 Fluid Block Anti-Fog Tie-on Surgical Mask and 3M 1830FS Fluid Block…	Minnesota Mining and Mfg. Co.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K965043, 1991–1997Source: 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

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What was it cleared against? (2)

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
*	K940707	3M Surgical Mask with Face Sheild Summary page 1 …ical Mask with Face Shield Surgical Mask Surgical Apparel, Class Ii, 21 CFR 878.4040 3M 1818 Tie-on Surgical Mask and 3M 1818FS Tie- On Surgical Mask with Face Shield (K940707). Tecnol FluidShield(R) Surgical Masks (K913043). The 1830/1830F S is a flat, pleated, tie-on mask consisting of inner and outer…	3M Company	1994	—
*	K913043	Modification Tecnol Fluidshield Surgical Masks Summary page 1 …al Apparel, Class Ii, 21 CFR 878.4040 3M 1818 Tie-on Surgical Mask and 3M 1818FS Tie- On Surgical Mask with Face Shield (K940707). Tecnol FluidShield(R) Surgical Masks (K913043). The 1830/1830F S is a flat, pleated, tie-on mask consisting of inner and outer cover webs with two different filter webs sandw…	Tecnol New Jersey Wound Care, Inc.	1991	—

Also cleared against K940707: 1 other device →

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 2 ancestors has a recall.
1 other device also cites its predicate K940707.

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?

The product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms. In addition, the device is intended to reduce potential exposure of the wearer to blood and body fluids.

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/K965043 · printed Nov 5, 2026

Cite this page

510(k) Report. “K965043: 3M 1830 Fluid Block Anti-Fog Tie-on Surgical Mask and 3M 1830FS Fluid Block Anti-Fog Tie-on Surgical Mask with Face Shie.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965043

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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