510(k) · Cleared
ClearedAsept Surgical Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pfm Medical, Inc. · FXX Mask, Surgical
Cleared on Aug 19, 2020 as substantially equivalent to K111559 (Shanghai Neo-Medical Import & Export Co., Ltd., 2011) after a 113-day review. Its family tree reaches back 7 generations to 1987. 3 later devices descend from it.
- Decided
- Aug 19, 2020
- Review
- 113 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K874608 (1987). 10 ancestors in all, the oldest K801036 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 6 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 5 generations backK012602 Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid…Crosstex Intl. · 2002
- 4 generations backK040333 Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach)…Valumax Intl., Inc. · 2004
- 3 generations backK051291 Non-Sterile Surgical MaskA.R. Medicom, Inc. · 2005 · Recalled
- 2 generations backK061864 Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540…Dukal Corp. · 2006
- 1 generation backK111559 Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd. · 2011
- This deviceK201137 Asept Surgical Face MaskPfm Medical, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK203200 Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK210643 Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK203174 Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K203200Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd. · 2021 · cites it directly1descendant
- K210643Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd. · 2021 · 2 generations on0descendants
- K203174Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −6 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −5 | K012602 | Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face… | Crosstex Intl. | 2002 | — |
| −4 | K040333 | Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or… | Valumax Intl., Inc. | 2004 | — |
| −3 | K051291 | Non-Sterile Surgical Mask | A.R. Medicom, Inc. | 2005 | 5 |
| −2 | K061864 | Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with… | Dukal Corp. | 2006 | — |
| −1 | K111559 | Surgical Masks | Shanghai Neo-Medical Import & Export Co., Ltd. | 2011 | — |
| 0 (this device) | K201137 | Asept Surgical Face Mask | Pfm Medical, Inc. | 2020 | — |
| +1 | K203200 | Disposable Medical Surgical Face Mask | Guangdong Haiou Medical Apparatus Co., Ltd. | 2021 | — |
| +2 | K210643 | Disposable Surgical Face Mask | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021 | — |
| +1 | K203174 | Disposable Medical Mask | Dong Guan Kinyet Metal Products Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2021 | 3 | 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 |
|---|---|---|---|
| * | K111559 | Surgical MasksSummary page 4…sification Name: Surgical Apparel Product Code: FXX Regulation Number: 21 CFR §878.4040 Predicate Device Information Trade Name: Surgical Masks Premarket Notification: K111559 Product Code: FXX, Regulation Number: 21 CFR §878.4040 Manufacturer: Shanghai Neo-Medical Import & Export Co. Device Description… | 2011 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 33 years and passes through 8 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K203200 (Guangdong Haiou Medical Apparatus Co., Ltd., 2021) has gone furthest, with 1 descendant 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. 2020, 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?
The ASEPT® Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201137: Asept Surgical Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201137
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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