510(k) · Cleared
ClearedPRIMED Surgical Masks and PRIMED Procedure Masks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primed Medical Products, Inc. · FXX Mask, Surgical
Cleared on Aug 26, 2024 as substantially equivalent to K081633 (Primed Medical Products, Inc., 2008) after a 207-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Aug 26, 2024
- Review
- 207 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001951 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001951 Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated…Primeline Medical Products, Inc. · 2000
- 1 generation backK081633 Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksPrimed Medical Products, Inc. · 2008
- This deviceK240286 PRIMED Surgical Masks and PRIMED Procedure MasksPrimed Medical Products, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK252964 PRIMED Surgical and Procedure MasksPrimed Medical Products, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252964PRIMED Surgical and Procedure MasksPrimed Medical Products, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001951 | Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop… | Primeline Medical Products, Inc. | 2000 | — |
| −1 | K081633 | Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face Masks | Primed Medical Products, Inc. | 2008 | — |
| 0 (this device) | K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | Primed Medical Products, Inc. | 2024 | — |
| +1 | K252964 | PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K081633 | Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksSummary page 5…21 CFR 878.4040 Device Class: 2 Product Code: FXX Predicate device(s) PRIMAGARD Surgical Masks, # K081633 Device Description: PRIMED Surgical masks and PRIMED Procedure masks are single use, non-sterile masks composed of a m… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252964 | PRIMED Surgical and Procedure Masks | 2025 | 0 |
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 24 years and passes through 2 companies; a new generation was cleared every 16.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252964 (Primed Medical Products, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081633.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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?
PRIMED Surgical Masks and PRIMED Procedure Masks are single use, non-sterile products intended to be worn by
operating room and health care personnel in health care setting and during surgical procedures to protect both the patient
and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.
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/K240286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240286: PRIMED Surgical Masks and PRIMED Procedure Masks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240286
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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