510(k) · Cleared
ClearedMedicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amd Medicom, Inc. · OXZ Pediatric/Child Facemask
Cleared on Sep 17, 2019 as substantially equivalent to K160100 (Prestige Ameritech, 2016) after a 217-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Sep 17, 2019
- Review
- 217 days
- Class
- Class II
- Product code
- OXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K970835 (1997). 12 ancestors in all, the oldest K801036 (1980). No later device cites it as a predicate yet.
- Root · 7 generations backK970835 Face Mask, Surgical Mask, Non-SterileTucker & Associates · 1997
- 6 generations backK022256 Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and GreenTucker & Associates · 2004
- 5 generations backK060776 Surgical Face MaskHong YA Non-Woven Products Co., Ltd. · 2006
- 4 generations backK061716 Prestige Ameritech Face MaskPrestige Ameritech · 2006
- 3 generations backK103150 Kimberly-Clark Child/Pediatric Face MaskKimberly-Clark · 2011
- 2 generations backK113340 Kimberly-Clark Child's FacemaskKimberly-Clark · 2012
- 1 generation backK160100 Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech · 2016
- This deviceK190308 Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks…Amd Medicom, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970835 | Face Mask, Surgical Mask, Non-Sterile | Tucker & Associates | 1997 | — |
| −6 | K022256 | Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green | Tucker & Associates | 2004 | — |
| −5 | K060776 | Surgical Face Mask | Hong YA Non-Woven Products Co., Ltd. | 2006 | — |
| −4 | K061716 | Prestige Ameritech Face Mask | Prestige Ameritech | 2006 | — |
| −3 | K103150 | Kimberly-Clark Child/Pediatric Face Mask | Kimberly-Clark | 2011 | — |
| −2 | K113340 | Kimberly-Clark Child's Facemask | Kimberly-Clark | 2012 | — |
| −1 | K160100 | Prestige Ameritech Pediatric/Child’s Face mask | Prestige Ameritech | 2016 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K160100 | Prestige Ameritech Pediatric/Child’s Face maskSummary page 5…device that is recommended for use in healthcare settings with appropriate adult supervision. Predicate Device (K160100) Comparison of the Technological Characteristics with the Predicate The table below compares the construction,… | 2016 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 2 other devices also cite its predicate K160100.
How does its category compare?
All OXZ devicesOXZ Pediatric/Child Facemask: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask, Medicom SafeMask Premier Pediatric Procedure Earloop Face Mask (ASTM Level 1) and Medicom SafeMask Premier Pediatric Procedure Earloop Face Mask are intended to be worn by the patient/child (recommended 4-12 years of age). The face mask is to be placed on nose and mouth as a protective barrier to provide…
Read the full statement (108 words)
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask, Medicom SafeMask Premier Pediatric Procedure Earloop Face Mask (ASTM Level 1) and Medicom SafeMask Premier Pediatric Procedure Earloop Face Mask are intended to be worn by the patient/child (recommended 4-12 years of age). The face mask is to be placed on nose and mouth as a protective barrier to provide respiratory protection in procedures or situations where there is a risk of microorganism, body fluid and particulate aerosol transfer. It is a single use, non-sterile disposable device that is recommended for use in healthcare settings with appropriate adult supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190308: Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190308
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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