510(k) · Cleared
ClearedSterile Gauze PK Strips Sat W/Carr Gel Wound Dress
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carrington Laboratories, Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Jan 31, 1992 after an 85-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 27 later devices descend from it.
- Decided
- Jan 31, 1992
- Review
- 85 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 1 citing it directly.
- This deviceK915002 Sterile Gauze PK Strips Sat W/Carr Gel Wound DressCarrington Laboratories, Inc. · 1992
- Descendant · cites it directly · 26 of its ownK090092 Sockit! and Mcmerlin Dermal Wound GelMcmerlin Dental Products LP · 2009
- Descendant · 2 generations on · 25 of its ownK093585 Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 17 of its ownK102945 Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011
- Descendant · 3 generations on · 11 of its ownK123071 Vashe Skin and Wound HydrogelPuricore, Inc. · 2013
- Descendant · 3 generations on · 10 of its ownK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K090092Sockit! and Mcmerlin Dermal Wound GelMcmerlin Dental Products LP · 2009 · cites it directly26descendants
- K093585Microcyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. · 2010 · 2 generations on25descendants
- K102945Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011 · 2 generations on17descendants
- K123071Vashe Skin and Wound HydrogelPuricore, Inc. · 2013 · 3 generations on11descendants
- K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915002 | Sterile Gauze PK Strips Sat W/Carr Gel Wound Dress | Carrington Laboratories, Inc. | 1992 | — |
| +1 | K090092 | Sockit! and Mcmerlin Dermal Wound Gel | Mcmerlin Dental Products LP | 2009 | — |
| +2 | K093585 | Microcyn Skin and Wound Hydrogel | Oculus Innovative Sciences, Inc. | 2010 | 1 |
| +2 | K102945 | Pediacyn Atopic Dermatitis Hydrogel | Oculus Innovative Sciences, Inc. | 2011 | — |
| +3 | K123071 | Vashe Skin and Wound Hydrogel | Puricore, Inc. | 2013 | — |
| +3 | K141863 | Puricore Wound Hydrogel Spray Dressing | Puricore, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 MGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090092 | Sockit! and Mcmerlin Dermal Wound Gel | 2009 | 26 |
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?
- Of its descendants, K090092 (Mcmerlin Dental Products LP, 2009) has gone furthest, with 26 descendants of its own.
How does its category compare?
All MGQ devicesMGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MGQ
Too few MGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGQ
4in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 2025
MAUDE reports naming product code MGQ, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 4 | 10 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K915002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915002: Sterile Gauze PK Strips Sat W/Carr Gel Wound Dress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915002
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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