510(k) · Cleared
ClearedMedline Prohibit Series Surgical Mask with Fluid Shield
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · FXX Mask, Surgical
Cleared on Aug 23, 1999 after a 111-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Aug 23, 1999
- Review
- 111 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK991559 Medline Prohibit Series Surgical Mask with Fluid ShieldMedline Industries, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK100846 Imc Surgical Face MaskInternational Medsurg Connection · 2010
- Descendant · 2 generations on · 0 of its ownK212375 Disposable Medical Surgical MaskJiangxi Bestgrand Health Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK202954 Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK210429 Disposable Surgical Face MaskJiangxi Heying Pharmaceutical Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K100846Imc Surgical Face MaskInternational Medsurg Connection · 2010 · cites it directly3descendants
- K212375Disposable Medical Surgical MaskJiangxi Bestgrand Health Technology Co., Ltd. · 2022 · 2 generations on0descendants
- K202954Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd. · 2021 · 2 generations on0descendants
- K210429Disposable Surgical Face MaskJiangxi Heying Pharmaceutical Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991559 | Medline Prohibit Series Surgical Mask with Fluid Shield | Medline Industries, Inc. | 1999 | — |
| +1 | K100846 | Imc Surgical Face Mask | International Medsurg Connection | 2010 | — |
| +2 | K212375 | Disposable Medical Surgical Mask | Jiangxi Bestgrand Health Technology Co., Ltd. | 2022 | — |
| +2 | K202954 | Disposable Surgical Mask | Xiamen Probtain Medical Techology Co., Ltd. | 2021 | — |
| +2 | K210429 | Disposable Surgical Face Mask | Jiangxi Heying Pharmaceutical Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K100846 | Imc Surgical Face Mask | 2010 | 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?
- Of its descendants, K100846 (International Medsurg Connection, 2010) has gone furthest, with 3 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?
A surgical mask is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991559: Medline Prohibit Series Surgical Mask with Fluid Shield.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991559
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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