510(k) · Cleared
ClearedRacal N95 Resirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Racal Filter Technologies, Inc. · FXX Mask, Surgical
Cleared on Feb 7, 1997 as substantially equivalent to K955382 (3M Company, 1996) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Feb 7, 1997
- Review
- 74 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922507 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922507 | Gerson Isolair Apr Particulate Surgical Mask | Louis M. Gerson Co., Inc. | 1992 | — |
| −1 | K960778 | Isolair Apr Type N95 | Louis M. Gerson Co., Inc. | 1996 | — |
| 0 (this device) | K964723 | Racal N95 Resirator | Racal Filter Technologies, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K955382 | 3M Model 1860 Health Care Particulate Respirator Type N95Summary page 2…acturers Racal Health & Safety M Louis M Gerson Device RACAL N95 Model 1860 Health Care lsolair APR Type N95 Respirartors Respirators Respirators 510(k) Number K964723 K955382 K960778 Standurds Met Performance Performance Performance Code of Federal Regulationy, Cocle of Federal Regulation§ Code of Fede… | 1996 |
| * | K960778 | Isolair Apr Type N95Summary page 2…Racal Health & Safety M Louis M Gerson Device RACAL N95 Model 1860 Health Care lsolair APR Type N95 Respirartors Respirators Respirators 510(k) Number K964723 K955382 K960778 Standurds Met Performance Performance Performance Code of Federal Regulationy, Cocle of Federal Regulation§ Code of Federal Regu… | 1996 |
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K955382.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FXX
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FXX
123in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FXX
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FXX
11in 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 Racal N93 Respirator and Surgical Mask will be used for the protection of the health care practitioner from blood and body fluids and particulates and to meet the NIOSH / CDC TB Prevention Guidelines.
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/K964723 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964723: Racal N95 Resirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964723
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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