510(k) · Cleared
ClearedSkypro, SP01 Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skypro Medical Supplies Company · FXX Mask, Surgical
Cleared on Aug 26, 2016 as substantially equivalent to K141875 (Pasture Pharma Pte, Ltd., 2015) after a 387-day review. Its family tree reaches back 7 generations to 1987. 2 later devices descend from it.
- Decided
- Aug 26, 2016
- Review
- 387 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). 2 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 backK092580 Tidi FacemaskTidi Products,Llc · 2010
- 1 generation backK141875 Pasture 60S Surgical MaskPasture Pharma Pte, Ltd. · 2015
- This deviceK152197 Skypro, SP01 MaskSkypro Medical Supplies Company · 2016
- Descendant · cites it directly · 0 of its ownK202255 Skypro, SP02 Mask (3)Skypro Medical Supplies Company · 2021
- Descendant · cites it directly · 0 of its ownK203646 Disposable Medical Face MaskGuangzhou Mei YI Kang Medical Technology Co., Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See allView 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 | K092580 | Tidi Facemask | Tidi Products,Llc | 2010 | — |
| −1 | K141875 | Pasture 60S Surgical Mask | Pasture Pharma Pte, Ltd. | 2015 | — |
| 0 (this device) | K152197 | Skypro, SP01 Mask | Skypro Medical Supplies Company | 2016 | — |
| +1 | K202255 | Skypro, SP02 Mask (3) | Skypro Medical Supplies Company | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K141875 | Pasture 60S Surgical MaskSummary page 5…: General and Plastic Surgery Product Code: FXX Device Common Name/ Classification Name: Surgical Mask Recognized Performance Predicate Device Pasture 60S Surgical Mask K141875 Labels/ Labeling: Skypro, SP01 Mask will be marketed as single use disposable procedure mask and this product is not made with n… | 2015 |
What descends from it? (2)
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 29 years and passes through 8 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K202255 (Skypro Medical Supplies Company, 2021) has gone furthest, with 0 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. 2016, 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 Skypro, SP01 Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152197: Skypro, SP01 Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152197
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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