510(k) · Cleared
ClearedCollatek Hydrogel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocore Medical Technologies, Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Dec 2, 2002 as substantially equivalent to K991202 (Coloplast Corp., 1999) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1997. 106 later devices descend from it.
- Decided
- Dec 2, 2002
- Review
- 84 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973688 (1997). 5 ancestors in all, the oldest K894541 (1989). 106 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- 1 generation backK983362 NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
- This deviceK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- Descendant · cites it directly · 97 of its ownK040019 SilversealNoble Fiber Technologies · 2004
- Descendant · 2 generations on · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · 3 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- Descendant · 4 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · See all- K040019SilversealNoble Fiber Technologies · 2004 · cites it directly97descendants
- K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · 2 generations on73descendants
- K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 3 generations on66descendants
- K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 4 generations on37descendants
- K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973688 | Duoderm Control Gel Formula Border Dressing | Convatec, Ltd. | 1997 | — |
| −1 | K983362 | NU-Gel * Wound Dressing | Johnson & Johnson Medical, Inc. | 1998 | — |
| 0 (this device) | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| +1 | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| +2 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +3 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| +4 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
| +4 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 9 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 7 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 5 | 0 |
| 2026 | 13 | 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 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? (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 |
|---|---|---|---|
| * | K991202 | Modification to Woun'dresSummary page 1…Predicate Device: Trade name: Woun’Dres Collagen Hydrogel Wound Dressing Company: Coloplast Corporation 5 10(k) number: K99 1202 Date Approved: June 4, 1999 Trade name: Nu-Gel Wound Dressing Company: Johnson a… | 1999 |
| * | K983362 | NU-Gel * Wound DressingSummary page 1…ed: June 4, 1999 Trade name: Nu-Gel Wound Dressing Company: Johnson and Johnson Medical Inc. 5 1O(k) number: K983362 Date Approved: December 16, 1998 Device Description: Collatek Hydrogel is a sterile wound-dressing from polyacrylic… | 1998 |
What descends from it? (106)
See all 1063 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 5 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K040019 (Noble Fiber Technologies, 2004) has gone furthest, with 97 descendants of its own.
- 5 other devices also cite its predicate K991202.
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 | — |
What is it indicated for?
Collatek is indicated for dry, light and moderately exudating partial and full thickness wounds such as:
First and second degree bums
Severe sunburns
Superficial injuries, cuts, abrasions and surgical wounds
Collatek Hydrogel may be used under clinical guidance in the management of the followink types of dry, light and moderately exudating partial and full thickness wounds:
Pressure (stage I-IV) and venous stasis ulcers
Ulcers caused by mixed vascular etiologies
Diabetic ulcers
Donor sites and grafts
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022995 · printed Nov 3, 2026
Cite this page
510(k) Report. “K022995: Collatek Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K022995
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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