510(k) · Cleared
ClearedPrimed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop, Procedure Mask PM4-306
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primeline Medical Products, Inc. · FXX Mask, Surgical
Cleared on Sep 8, 2000 after a 73-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Sep 8, 2000
- Review
- 73 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK001951 Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated…Primeline Medical Products, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK081633 Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksPrimed Medical Products, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK240286 PRIMED Surgical Masks and PRIMED Procedure MasksPrimed Medical Products, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK252964 PRIMED Surgical and Procedure MasksPrimed Medical Products, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK092012 Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium…Primed Medical Products, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K081633Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksPrimed Medical Products, Inc. · 2008 · cites it directly3descendants
- K240286PRIMED Surgical Masks and PRIMED Procedure MasksPrimed Medical Products, Inc. · 2024 · 2 generations on1descendant
- K252964PRIMED Surgical and Procedure MasksPrimed Medical Products, Inc. · 2025 · 3 generations on0descendants
- K092012Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model…Primed Medical Products, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | Primed Medical Products, Inc. | 2024 | — |
| +3 | K252964 | PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. | 2025 | — |
| +2 | K092012 | Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large)… | Primed Medical Products, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081633 | Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face Masks | 2008 | 3 |
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?
- Of its descendants, K081633 (Primed Medical Products, Inc., 2008) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K001951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001951: Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop, Procedure Mask PM4-306.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001951
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026