510(k) · Cleared
ClearedPRIMED Pediatric Facemask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primed Medical Products, Inc. · OXZ Pediatric/Child Facemask
Cleared on Nov 22, 2022 as substantially equivalent to K210321 (Dukal Corporation, 2022) and 1 other predicate after a 397-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Nov 22, 2022
- Review
- 397 days
- Class
- Class II
- Product code
- OXZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K970835 (1997). 13 ancestors in all, the oldest K801036 (1980). No later device cites it as a predicate yet.
- Root · 8 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 7 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 6 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 5 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- 4 generations backK103150 Kimberly-Clark Child/Pediatric Face MaskKimberly-Clark · 2011
- 3 generations backK113340 Kimberly-Clark Child's FacemaskKimberly-Clark · 2012
- 2 generations backK160100 Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech · 2016
- 1 generation backK210321 Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation · 2022
- This deviceK213427 PRIMED Pediatric FacemaskPrimed Medical Products, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −7 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −6 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −5 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| −4 | K103150 | Kimberly-Clark Child/Pediatric Face Mask | Kimberly-Clark | 2011 | — |
| −3 | K113340 | Kimberly-Clark Child's Facemask | Kimberly-Clark | 2012 | — |
| −2 | K160100 | Prestige Ameritech Pediatric/Child’s Face mask | Prestige Ameritech | 2016 | — |
| −1 | K210321 | Dukal Corporation Level 1 Pediatric Face Mask | Dukal Corporation | 2022 | — |
| 0 (this device) | K213427 | PRIMED Pediatric Facemask | Primed Medical Products, Inc. | 2022 | — |
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 |
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
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 |
|---|---|---|---|
| * | K210321 | Dukal Corporation Level 1 Pediatric Face Mask Cleared while this submission was under review Summary page 4…2 Product Code: OXZ (Pediatric/Child Facemask) Predicate device(s) Dukal level 1 Pediatric face mask 510(k)#: K210321 Kimberly-Clark Child’s Facemask 510(k)#: K113340 The… | 2022 |
| * | K113340 | Kimberly-Clark Child's FacemaskSummary page 4…) Predicate device(s) Dukal level 1 Pediatric face mask 510(k)#: K210321 Kimberly-Clark Child’s Facemask 510(k)#: K113340 The PRIMED level 1 Pediatric Facemask is a single use, disposable Device Description… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 6 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
How does its category compare?
All OXZ devicesOXZ Pediatric/Child Facemask: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 PRIMED level 1 Pediatric Facemask is a single use, disposable device that is intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to provide a barrier for the respiratory tract from microorganisms, body fluids and particulate material.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213427 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213427: PRIMED Pediatric Facemask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213427
Report an extraction error
Are you the manufacturer?
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