510(k) · Cleared
ClearedMedical Surgical Mask (HH1001), Respiratory Mask (HH1002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H&H Research Company · FXX Mask, Surgical
Cleared on Jul 14, 2010 as substantially equivalent to K092580 (Tidi Products,Llc, 2010) and 2 other predicates after a 279-day review. Its family tree reaches back 6 generations to 1987. 3 later devices descend from it.
- Decided
- Jul 14, 2010
- Review
- 279 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K874608 (1987). 11 ancestors in all, the oldest K801036 (1980). 3 later devices descend from it, 2 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 deviceK093179 Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company · 2010
- Descendant · cites it directly · 1 of its ownK202139 Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK213450 Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK202577 Medical Surgical Mask-Model MP002-5, MP002-6Jiangmen Sure&Me Medical Product Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K202139Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2020 · cites it directly1descendant
- K213450Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022 · 2 generations on0descendants
- K202577Medical Surgical Mask-Model MP002-5, MP002-6Jiangmen Sure&Me Medical Product Co., Ltd. · 2021 · cites it directly0descendants
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) | K093179 | Medical Surgical Mask (HH1001), Respiratory Mask (HH1002) | H&H Research Company | 2010 | — |
| +1 | K202139 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020 | — |
| +2 | K213450 | Medical surgical mask (Black mask, Level 1 and Level 3) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
| +1 | K202577 | Medical Surgical Mask-Model MP002-5, MP002-6 | Jiangmen Sure&Me Medical Product Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 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? (3)
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 Facemask Cleared while this submission was under review Summary page 1…e and Product Code: Medical Mask; Surgical Apparel (2 1CFR878.4040) Product Code: FXX SUMMARY STATEMENT: Predicate Products: TIDITm Facemask. Tidi Products, LLC: K092580 Spunguard Mask, Kimberly-Clark: K823078 3M Particulate Respirator and Surgical Mask Model… | 2010 |
| * | K823078 | Spunguard Face MaskSummary page 1…R878.4040) Product Code: FXX SUMMARY STATEMENT: Predicate Products: TIDITm Facemask. Tidi Products, LLC: K092580 Spunguard Mask, Kimberly-Clark: K823078 3M Particulate Respirator and Surgical Mask Model 1870: K063023 Comparison of Intended Use: This product is… | 1983 |
| * | K063023 | 3M Health Care Particulate Respirator and Surgical Mask, Model 1870Summary page 1…mask. Tidi Products, LLC: K092580 Spunguard Mask, Kimberly-Clark: K823078 3M Particulate Respirator and Surgical Mask Model 1870: K063023 Comparison of Intended Use: This product is indicated for infection control practices in the health care industry. When worn p… | 2007 |
What descends from it? (3)
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 23 years and passes through 7 companies; a new generation was cleared every 4.4 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K202139 (Guangdong Kingfa Sci. & Tech.Co., Ltd., 2020) has gone furthest, with 1 descendant 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. 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 product is indicated for infection control practices in the health care industry.
When worn properly, The New Medical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093179 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093179: Medical Surgical Mask (HH1001), Respiratory Mask (HH1002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093179
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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