# K181428: Clyra Wound Irrigation Solution

- Pathway: 510(k) (Traditional)
- Applicant: Clyra Medical Technologies, Inc.
- Decided: Sep 20, 2019 after 476 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K914579 (1992). 44 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133542: Puracyn Plus Skin and Wound, Innovacyn, Inc. (2014). Our reading of the summary gave K133452, FDA’s number for Emerge Medical Small Fragment Locked Plating System (Emerge Medical). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Puracyn Plus Skin and Wound Care”. Summary page 6.

## Most influential descendants
- K202071: SURGIPHOR Wound Irrigation System (2020), 4 descendants of its own
- K213616: BD Surgiphor Antimicrobial Irrigation System (2022), 3 descendants of its own
- K221504: BD Surgiphor™ Antimicrobial Irrigation System (2022), 2 descendants of its own
- K253996: BD Surgiphor™ Antimicrobial Irrigation System (910110) (2026), 0 descendants of its own
- K253445: BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (2026), 0 descendants of its own

## Indications for use
Clyra Wound Irrigation Solution is intended for use by healthcare professionals for cleansing, irrigating, moistening and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic ulcers, stasis ulcers, abrasions and minor skin irritations, post surgical wounds, grafted and donor sites, in addition to moistening and lubricating absorbent wound dressings.

Source page: https://510kreport.com/device/K181428
Methodology: https://510kreport.com/methodology