510(k) · Cleared
ClearedSurgical Masks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Neo-Medical Import & Export Co., Ltd. · FXX Mask, Surgical
Cleared on Sep 16, 2011 as substantially equivalent to K061864 (Dukal Corp., 2006) after a 102-day review. Its family tree reaches back 6 generations to 1987. 4 later devices descend from it.
- Decided
- Sep 16, 2011
- Review
- 102 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K874608 (1987). 9 ancestors in all, the oldest K801036 (1980). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 5 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 4 generations backK012602 Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid…Crosstex Intl. · 2002
- 3 generations backK040333 Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach)…Valumax Intl., Inc. · 2004
- 2 generations backK051291 Non-Sterile Surgical MaskA.R. Medicom, Inc. · 2005 · Recalled
- 1 generation backK061864 Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540…Dukal Corp. · 2006
- This deviceK111559 Surgical MasksShanghai Neo-Medical Import & Export Co., Ltd. · 2011
- Descendant · cites it directly · 3 of its ownK201137 Asept Surgical Face MaskPfm Medical, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK203200 Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK210643 Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK203174 Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K201137Asept Surgical Face MaskPfm Medical, Inc. · 2020 · cites it directly3descendants
- K203200Disposable Medical Surgical Face MaskGuangdong Haiou Medical Apparatus Co., Ltd. · 2021 · 2 generations on1descendant
- K210643Disposable Surgical Face MaskShandong Zhushi Pharmaceutical Group Co., Ltd. · 2021 · 3 generations on0descendants
- K203174Disposable Medical MaskDong Guan Kinyet Metal Products Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −5 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −4 | K012602 | Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face… | Crosstex Intl. | 2002 | — |
| −3 | K040333 | Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or… | Valumax Intl., Inc. | 2004 | — |
| −2 | K051291 | Non-Sterile Surgical Mask | A.R. Medicom, Inc. | 2005 | 5 |
| −1 | K061864 | Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with… | Dukal Corp. | 2006 | — |
| 0 (this device) | K111559 | Surgical Masks | Shanghai Neo-Medical Import & Export Co., Ltd. | 2011 | — |
| +1 | K201137 | Asept Surgical Face Mask | Pfm Medical, Inc. | 2020 | — |
| +2 | K203200 | Disposable Medical Surgical Face Mask | Guangdong Haiou Medical Apparatus Co., Ltd. | 2021 | — |
| +3 | K210643 | Disposable Surgical Face Mask | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021 | — |
| +2 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K061864 | Dukal Surgical Face Mask Tie-on, Model 1530; Ear Loop, Model 1540; with Shield, Model 1560Summary page 2…are indicated in any procedure or situation where there is a risk of microorganism, body fluid. 5. Predicate Device Identification 5 10O(k) Number: K061864 Product Name: Non Sterile Surgical Mask Manufacturer: Dukal Corporation 6. Device Description The Su… | 2006 |
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 |
|---|---|---|---|
| K201137 | Asept Surgical Face Mask | 2020 | 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?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K201137 (Pfm Medical, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K061864.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Surgical Masks are 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 microorganism, body fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111559: Surgical Masks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111559
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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