510(k) · Cleared
ClearedPasture 60S Surgical Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pasture Pharma Pte, Ltd. · FXX Mask, Surgical
Cleared on May 5, 2015 as substantially equivalent to K092580 (Tidi Products,Llc, 2010) after a 298-day review. Its family tree reaches back 6 generations to 1987. 3 later devices descend from it.
- Decided
- May 5, 2015
- Review
- 298 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). 3 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 backK092580 Tidi FacemaskTidi Products,Llc · 2010
- This deviceK141875 Pasture 60S Surgical MaskPasture Pharma Pte, Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK152197 Skypro, SP01 MaskSkypro Medical Supplies Company · 2016
- Descendant · 2 generations on · 0 of its ownK202255 Skypro, SP02 Mask (3)Skypro Medical Supplies Company · 2021
- Descendant · 2 generations on · 0 of its ownK203646 Disposable Medical Face MaskGuangzhou Mei YI Kang Medical Technology Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K152197Skypro, SP01 MaskSkypro Medical Supplies Company · 2016 · cites it directly2descendants
- K202255Skypro, SP02 Mask (3)Skypro Medical Supplies Company · 2021 · 2 generations on0descendants
- K203646Disposable Medical Face MaskGuangzhou Mei YI Kang Medical Technology 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 | K092580 | Tidi Facemask | Tidi Products,Llc | 2010 | — |
| 0 (this device) | K141875 | Pasture 60S Surgical Mask | Pasture Pharma Pte, Ltd. | 2015 | — |
| +1 | K152197 | Skypro, SP01 Mask | Skypro Medical Supplies Company | 2016 | — |
| +2 | K202255 | Skypro, SP02 Mask (3) | Skypro Medical Supplies Company | 2021 | — |
| +2 | K203646 | Disposable Medical Face Mask | Guangzhou Mei YI Kang Medical Technology 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K092580 | Tidi FacemaskSummary page 5…tic Surgery Product Code: FXX Common name: Surgical Mask Regulatory Reference: 21 CFR 878.4040 Predicate Device: TIDI PRODUCTS, LLC TIDI® Facemasks K092580 Labels/ Labeling: Pasture 60S Surgical Mask will be marketed as single use disposable surgical mask for the Intended Use p… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152197 | Skypro, SP01 Mask | 2016 | 2 |
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 28 years and passes through 7 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K152197 (Skypro Medical Supplies Company, 2016) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K092580.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Pasture 60S Surgical Mask is a surgical mask that is indicated to be used by the healthcare personnel during procedures to
protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate
material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141875: Pasture 60S 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/K141875
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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