510(k) · Cleared
ClearedPRIMED AAMI Level 3 Open Back Gowns
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PRIMED Medical Products, Inc. · QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Cleared on Sep 11, 2026 as substantially equivalent to K233526 (Medline Industries, LP, 2024) after an 88-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Sep 11, 2026
- Review
- 88 days
- Class
- Class II
- Product code
- QPC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K925077 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK925077 Poly-Med Disp. Pers. Prot. Gown Apron & ShoecoversMedtek Development Corp. · 1993
- 3 generations backK160337 Safecare Open Back Protective Gowns and ValueCare Open Back…Bam Corporation Limited · 2017
- 2 generations backK210405 ProTEC-USA EZDoff GownCadillac Products, Inc. · 2021
- 1 generation backK233526 Medline Open-back Level 3 Protective GownMedline Industries, LP · 2024
- This deviceK262007 PRIMED AAMI Level 3 Open Back GownsPRIMED Medical Products, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925077 | Poly-Med Disp. Pers. Prot. Gown Apron & Shoecovers | Medtek Development Corp. | 1993 | — |
| −3 | K160337 | Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns | Bam Corporation Limited | 2017 | — |
| −2 | K210405 | ProTEC-USA EZDoff Gown | Cadillac Products, Inc. | 2021 | — |
| −1 | K233526 | Medline Open-back Level 3 Protective Gown | Medline Industries, LP | 2024 | — |
| 0 (this device) | K262007 | PRIMED AAMI Level 3 Open Back Gowns | PRIMED Medical Products, Inc. | 2026 | — |
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 QPC? 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 QPC device
- #1 K233526 Medline Open-back Level 3 Protective Gownscore 10.6 · 3 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 |
|---|---|---|---|
| * | K233526 | Medline Open-back Level 3 Protective GownSummary page 6…Medline Open-Back Level 3 Protective Gown - 510k number K262007 K233526 - Manufacturer PRIMED Medical Products Inc.… | 2024 |
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 33 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All QPC devicesQPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QPC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QPC
Too few QPC 510(k)s in any year since 2007 to give a median.
Recalls per year · QPC
No recall names QPC since 2007.
Adverse event reports per year · QPC
No MAUDE report names QPC since 2007.
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 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
PRIMED AAMI Level 3 Open Back Gowns are non-sterile, single use gowns intended to be worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material in non-surgical, non-isolation settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K262007: PRIMED AAMI Level 3 Open Back Gowns.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K262007
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026