510(k) · Cleared
ClearedHY-Chlo (TM)Wound Scrub
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Patrin Pharma · FQH Lavage, Jet
Cleared on Aug 21, 2012 after a 286-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Aug 21, 2012
- Review
- 286 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK113312 HY-Chlo (TM)Wound ScrubPatrin Pharma · 2012
- Descendant · cites it directly · 0 of its ownK150208 Dakin's Skin and Wound CleanserCentury Pharmaceuticals, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K150208Dakin's Skin and Wound CleanserCentury Pharmaceuticals, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K113312 | HY-Chlo (TM)Wound Scrub | Patrin Pharma | 2012 | — |
| +1 | K150208 | Dakin's Skin and Wound Cleanser | Century Pharmaceuticals, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 FQH? 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 FQH device
- #1 K253996 BD Surgiphor™ Antimicrobial Irrigation System…score 14.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150208 | Dakin's Skin and Wound Cleanser | 2016 | 0 |
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, K150208 (Century Pharmaceuticals, Inc., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FQH
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FQH
410in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FQH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FQH
835in 2025
MAUDE reports naming product code FQH, 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 | 1 | — | 13 | 10 |
| 2008 | 0 | — | 0 | 27 |
| 2009 | 3 | 240 | 1 | 70 |
| 2010 | 0 | — | 7 | 135 |
| 2011 | 2 | — | 0 | 83 |
| 2012 | 1 | — | 0 | 133 |
| 2013 | 0 | — | 0 | 134 |
| 2014 | 0 | — | 0 | 194 |
| 2015 | 1 | — | 0 | 116 |
| 2016 | 1 | — | 0 | 150 |
| 2017 | 0 | — | 1 | 243 |
| 2018 | 0 | — | 0 | 317 |
| 2019 | 0 | — | 2 | 328 |
| 2020 | 3 | 130 | 0 | 393 |
| 2021 | 1 | — | 0 | 398 |
| 2022 | 4 | 136 | 0 | 171 |
| 2023 | 3 | 410 | 0 | 333 |
| 2024 | 0 | — | 0 | 425 |
| 2025 | 0 | — | 0 | 835 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
HyChioTh Wound Solution is intended for removal of foreign objects such as dirt, for cleansing of minor cuts, lacerations, abrasions and wounds.
HyChiorh Wound Solution is intended to be used under the supervision of healthcare professional in cleansing of acute, chronic and/or open wounds such as Stage J-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second degree burns and grafted and donor sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113312: HY-Chlo (TM)Wound Scrub.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113312
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