510(k) · Cleared
ClearedKimberly-Clark Child's Facemask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark · OXZ Pediatric/Child Facemask
Cleared on May 4, 2012 as substantially equivalent to K103150 (Kimberly-Clark, 2011) after a 172-day review. Its family tree reaches back 5 generations to 1997. 5 later devices descend from it.
- Decided
- May 4, 2012
- Review
- 172 days
- Class
- Class II
- Product code
- OXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K970835 (1997). 10 ancestors in all, the oldest K801036 (1980). 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 4 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 3 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 2 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- 1 generation backK103150 Kimberly-Clark Child/Pediatric Face MaskKimberly-Clark · 2011
- This deviceK113340 Kimberly-Clark Child's FacemaskKimberly-Clark · 2012
- Descendant · cites it directly · 4 of its ownK160100 Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech · 2016
- Descendant · 2 generations on · 1 of its ownK210321 Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK221753 Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK213427 PRIMED Pediatric FacemaskPrimed Medical Products, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK190308 Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks…Amd Medicom, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech · 2016 · cites it directly4descendants
- K210321Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation · 2022 · 2 generations on1descendant
- K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd. · 2023 · 2 generations on0descendants
- K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc. · 2022 · cites it directly0descendants
- K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom…Amd Medicom, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −4 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −3 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −2 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| −1 | K103150 | Kimberly-Clark Child/Pediatric Face Mask | Kimberly-Clark | 2011 | — |
| 0 (this device) | K113340 | Kimberly-Clark Child's Facemask | Kimberly-Clark | 2012 | — |
| +1 | K160100 | Prestige Ameritech Pediatric/Child’s Face mask | Prestige Ameritech | 2016 | — |
| +2 | K210321 | Dukal Corporation Level 1 Pediatric Face Mask | Dukal Corporation | 2022 | — |
| +2 | K221753 | Kangbeier Child Surgical Mask | Xinxiang Kangbeier Medical Technology Co., Ltd. | 2023 | — |
| +1 | K213427 | PRIMED Pediatric Facemask | Primed Medical Products, Inc. | 2022 | — |
| +2 | K190308 | Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level… | Amd Medicom, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 OXZ? 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 OXZ device
- #1 K221753 Kangbeier Child Surgical Maskscore 8.3 · 7 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 |
|---|---|---|---|
| * | K103150 | Kimberly-Clark Child/Pediatric Face MaskSummary page 1…, Class 11 Codes and Mask, surgical (21 CFR 878.4040) Classification Names: Predicate Devices The Kimberly-Clark Pediatric/Child face mask(s) K1 031 50. The Kimberly-Clark Pediatric/ Child Facemask is a three layer mask, const… | 2011 |
What descends from it? (5)
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 15 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K160100 (Prestige Ameritech, 2016) has gone furthest, with 4 descendants of its own.
How does its category compare?
All OXZ devicesOXZ Pediatric/Child Facemask: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OXZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OXZ
Too few OXZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OXZ
No recall names OXZ since 2007.
Adverse event reports per year · OXZ
1in 2023
MAUDE reports naming product code OXZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113340 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113340: Kimberly-Clark Child's Facemask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113340
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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