510(k) · Cleared
ClearedImc Surgical Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Medsurg Connection · FXX Mask, Surgical
Cleared on Aug 16, 2010 as substantially equivalent to K991559 (Medline Industries, Inc., 1999) and 1 other predicate after a 144-day review. Its family tree reaches back 3 generations to 1987. 3 later devices descend from it.
- Decided
- Aug 16, 2010
- Review
- 144 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K874608 (1987). 6 ancestors in all, the oldest K801036 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK874608 Tecnol Fluid Shield Surgical MaskTecnol New Jersey Wound Care, Inc. · 1987
- 2 generations backK955556 Fluid Resistant MaskAmerican Threshold Healthcare · 1996
- 1 generation backK012602 Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid…Crosstex Intl. · 2002
- This deviceK100846 Imc Surgical Face MaskInternational Medsurg Connection · 2010
- Descendant · cites it directly · 0 of its ownK212375 Disposable Medical Surgical MaskJiangxi Bestgrand Health Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK202954 Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK210429 Disposable Surgical Face MaskJiangxi Heying Pharmaceutical Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K212375Disposable Medical Surgical MaskJiangxi Bestgrand Health Technology Co., Ltd. · 2022 · cites it directly0descendants
- K202954Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd. · 2021 · cites it directly0descendants
- K210429Disposable Surgical Face MaskJiangxi Heying Pharmaceutical Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874608 | Tecnol Fluid Shield Surgical Mask | Tecnol New Jersey Wound Care, Inc. | 1987 | — |
| −2 | K955556 | Fluid Resistant Mask | American Threshold Healthcare | 1996 | — |
| −1 | K012602 | Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face… | Crosstex Intl. | 2002 | — |
| 0 (this device) | K100846 | Imc Surgical Face Mask | International Medsurg Connection | 2010 | — |
| +1 | K212375 | Disposable Medical Surgical Mask | Jiangxi Bestgrand Health Technology Co., Ltd. | 2022 | — |
| +1 | K202954 | Disposable Surgical Mask | Xiamen Probtain Medical Techology Co., Ltd. | 2021 | — |
| +1 | K210429 | Disposable Surgical Face Mask | Jiangxi Heying Pharmaceutical Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K991559 | Medline Prohibit Series Surgical Mask with Fluid ShieldSummary page 1…surg.com Date Prepared: June 7, 201 0 Predicate Devices: * Medline Prohibit Series Surgical Mask With Fluid Shield (K991559) * Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop… | 1999 |
| * | K012602 | Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face…Summary page 1…Series Surgical Mask With Fluid K99 1559 08/23/1999 Shield Crosstex Isolite Earloop, Crosstex Isolluid Earloop K012602 01/22/2002 Face Masks. Device Description The IMC Surgical Face Mask devices are surgical apparel intended to be… | 2002 |
What descends from it? (3)
3 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 23 years and passes through 4 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K212375 (Jiangxi Bestgrand Health Technology Co., Ltd., 2022) 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. 2010, 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?
This device is 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 as stated in the FDA summary.
https://510kreport.com/device/K100846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100846: Imc 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/K100846
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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