510(k) · Cleared
Recalled · Class II · 2023Non-Sterile Surgical Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.R. Medicom, Inc. · FXX Mask, Surgical
Cleared on Sep 20, 2005 as substantially equivalent to K955513 (United Medical Ent., Inc., 1996) and 1 other predicate after a 125-day review. Its family tree reaches back 4 generations to 1987. 20 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 20, 2005
- Review
- 125 days
- Class
- Class II
- Product code
- FXX
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 4 generations to K874608 (1987). 7 ancestors in all, the oldest K801036 (1980). 20 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 3 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 2 generations backK012602 Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid…Crosstex Intl. · 2002
- 1 generation backK040333 Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach)…Valumax Intl., Inc. · 2004
- This deviceK051291 Non-Sterile Surgical MaskA.R. Medicom, Inc. · 2005
- Descendant · cites it directly · 9 of its ownK092580 Tidi FacemaskTidi Products,Llc · 2010
- Descendant · cites it directly · 6 of its ownK061864 Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540…Dukal Corp. · 2006
- Descendant · 2 generations on · 4 of its ownK111559 Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd. · 2011
- Descendant · 3 generations on · 3 of its ownK201137 Asept Surgical Face MaskPfm Medical, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK141875 Pasture 60S Surgical MaskPasture Pharma Pte, Ltd. · 2015
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K092580Tidi FacemaskTidi Products,Llc · 2010 · cites it directly9descendants
- K061864Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560Dukal Corp. · 2006 · cites it directly6descendants
- K111559Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd. · 2011 · 2 generations on4descendants
- K201137Asept Surgical Face MaskPfm Medical, Inc. · 2020 · 3 generations on3descendants
- K141875Pasture 60S Surgical MaskPasture Pharma Pte, Ltd. · 2015 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −3 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −2 | K012602 | Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face… | Crosstex Intl. | 2002 | — |
| −1 | K040333 | Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or… | Valumax Intl., Inc. | 2004 | — |
| 0 (this device) | K051291 | Non-Sterile Surgical Mask | A.R. Medicom, Inc. | 2005 | — |
| +1 | K092580 | Tidi Facemask | Tidi Products,Llc | 2010 | — |
| +1 | K061864 | Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with… | Dukal Corp. | 2006 | — |
| +2 | K111559 | Surgical Masks | Shanghai Neo-Medical Import & Export Co., Ltd. | 2011 | — |
| +3 | K201137 | Asept Surgical Face Mask | Pfm Medical, Inc. | 2020 | — |
| +2 | K141875 | Pasture 60S Surgical Mask | Pasture Pharma Pte, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 7 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K955513 | Surgical Mask (Non-Sterile)Summary page 1…ASTM 2100-04 Refer to Appendix B for a list of applicable standards 5.4 Predicate Devices, 1. Surgical Mask (non-sterile), K9555 13 510(k) Number 2. Valumax Surgical Masks (Blue, Pink, Green, Yellow) K0… | 1996 |
| * | K040333 | Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or Without…Summary page 1…1. Surgical Mask (non-sterile), K9555 13 510(k) Number 2. Valumax Surgical Masks (Blue, Pink, Green, Yellow) K040333 5.5 Intended Use: The mnedical/surgical masks listed below are indicated a… | 2004 |
What descends from it? (20)
See all 207 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092580 | Tidi Facemask | 2010 | 9 |
| K061864 | Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560 | 2006 | 6 |
| K212273 | Cross Protection ResQ300 Plus Surgical Face Mask | 2022 | 0 |
| K203425 | Surgical Mask | 2021 | 0 |
| K110027 | Surgical Face Mask; Surgical Face Mask | 2011 | 0 |
| K100800 | Tidi Facemask | 2010 | 0 |
| K070407 | Dukal Surgical Face Mask Tie, Ear Loop, with Shield Yellow & White; Anti Fog Tie, Loop… | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2023 | Class II | Z-1148-2024 | Under Investigation by firm | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| Dec 21, 2023 | Class II | Z-1146-2024 | Under Investigation by firm | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| Dec 21, 2023 | Class II | Z-1147-2024 | Under Investigation by firm | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| Oct 11, 2019 | Class II | Z-0494-2020 | Under Investigation by firm | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended. |
| Oct 11, 2019 | Class II | Z-0495-2020 | Under Investigation by firm | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K092580 (Tidi Products,Llc, 2010) has gone furthest, with 9 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 | — |
What is it indicated for?
The medical/surgical masks listed below are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid, and particulate aerosol transfer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051291: Non-Sterile 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/K051291
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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