510(k) · Cleared
Recalled · Class II · 2024Spunguard Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · FXX Mask, Surgical
Cleared on Jan 7, 1983 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 7, 1983
- Review
- 80 days
- Class
- Class II
- Product code
- FXX
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK823078 Spunguard Face MaskKimberly-Clark Corp. · 1983
- Descendant · cites it directly · 3 of its ownK093179 Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company · 2010
- Descendant · 2 generations on · 1 of its ownK202139 Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK213450 Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK202577 Medical Surgical Mask-Model MP002-5, MP002-6Jiangmen Sure&Me Medical Product Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K093179Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)H&H Research Company · 2010 · cites it directly3descendants
- K202139Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2020 · 2 generations on1descendant
- K213450Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022 · 3 generations on0descendants
- K202577Medical Surgical Mask-Model MP002-5, MP002-6Jiangmen Sure&Me Medical Product 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) | K823078 | Spunguard Face Mask | Kimberly-Clark Corp. | 1983 | — |
| +1 | K093179 | Medical Surgical Mask (HH1001), Respiratory Mask (HH1002) | H&H Research Company | 2010 | — |
| +2 | K202139 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020 | — |
| +3 | K213450 | Medical surgical mask (Black mask, Level 1 and Level 3) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
| +2 | K202577 | Medical Surgical Mask-Model MP002-5, MP002-6 | Jiangmen Sure&Me Medical Product Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K093179 | Medical Surgical Mask (HH1001), Respiratory Mask (HH1002) | 2010 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2024 | Class II | Z-0729-2025 | Nonconforming Material/Component | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is… |
| Nov 8, 2024 | Class II | Z-0728-2025 | Nonconforming Material/Component | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093179 (H&H Research Company, 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 | — |
https://510kreport.com/device/K823078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K823078: Spunguard 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/K823078
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026