510(k) · Cleared
Clearedgel-e Flex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gel-E, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jun 22, 2018 as substantially equivalent to K072486 (Hem Con Medical Technologies, Inc., 2008) after a 154-day review. Its family tree reaches back 5 generations to 1997. 2 later devices descend from it.
- Decided
- Jun 22, 2018
- Review
- 154 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K972914 (1997). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK972914 Syvek PatchMarine Polymer Technologies, Inc. · 1997
- 4 generations backK023298 Hemcon BandageHemcon, Inc. · 2002
- 3 generations backK030946 Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc. · 2003
- 2 generations backK043050 Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc. · 2005
- 1 generation backK072486 Modification to Hemcon Bandage and Hemcon Bandage OtcHem Con Medical Technologies, Inc. · 2008 · Recalled
- This deviceK180152 gel-e FlexGel-E, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK213652 Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)Cresilon, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253609 TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K972914 | Syvek Patch | Marine Polymer Technologies, Inc. | 1997 | — |
| −4 | K023298 | Hemcon Bandage | Hemcon, Inc. | 2002 | — |
| −3 | K030946 | Hemcon Bandage Otc; Hemcon Cath/Aid | Hemcon, Inc. | 2003 | — |
| −2 | K043050 | Hemcon Bandage and Hemcon Bandage Otc | Hemcon, Inc. | 2005 | — |
| −1 | K072486 | Modification to Hemcon Bandage and Hemcon Bandage Otc | Hem Con Medical Technologies, Inc. | 2008 | 6 |
| 0 (this device) | K180152 | gel-e Flex | Gel-E, Inc. | 2018 | — |
| +1 | K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | Cresilon, Inc. | 2023 | — |
| +2 | K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 QSY? 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 QSY device
- #1 K240713 Traumagel®score 15.1 · 5 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 |
|---|---|---|---|
| * | K072486 | Modification to Hemcon Bandage and Hemcon Bandage OtcSummary page 5…314-9592 Jan 17,2018 gel-e Flex Dressing, Wound, Drug Unclassified Device (pre-amendment) Unclassified FRO Hemcon Medical Technologies’ Hemcon Bandage OTC Dressing (K072486) Hemcon Medical Technologies’ GuardaGel (K112215) gel-e’s Gel-e Bandage (K172010) Over-The-Counter Use (21 CFR 801 Subpart C):… | 2008 |
| † | K112215 | Hemcon Hemostatic Gel | 2012 |
| † | K172010 | gel-e Bandage | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | 2023 | 1 |
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 21 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K213652 (Cresilon, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K072486.
How does its category compare?
All QSY devicesQSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QSY
142in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QSY
No recall names QSY since 2007.
Adverse event reports per year · QSY
14in 2025
MAUDE reports naming product code QSY, 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 | 13 | 63 | 0 | 0 |
| 2008 | 7 | 61 | 0 | 0 |
| 2009 | 9 | 55 | 0 | 0 |
| 2010 | 7 | 75 | 0 | 0 |
| 2011 | 8 | 137 | 0 | 0 |
| 2012 | 7 | 239 | 0 | 0 |
| 2013 | 3 | 161 | 0 | 0 |
| 2014 | 6 | 249 | 0 | 0 |
| 2015 | 6 | 171 | 0 | 0 |
| 2016 | 5 | 161 | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 5 | 186 | 0 | 0 |
| 2019 | 4 | 336 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 7 | 586 | 0 | 0 |
| 2024 | 4 | 142 | 0 | 3 |
| 2025 | 2 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
gel-e Flex is indicated for the local management of bleeding such as laceration and minor bleeding.
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/K180152 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180152: gel-e Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180152
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