510(k) · Cleared

Cleared

Neutrophase Wound Cleanser

K071056510(k) TraditionalCleared Sep 28, 2007165-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Novabay Pharmaceuticals · FRO Dressing, Wound, Drug

Cleared on Sep 28, 2007 as substantially equivalent to K060113 (Oculus Innovative Sciences, Inc., 2006) and 1 other predicate after a 165-day review. Its family tree reaches back 4 generations to 1995. 17 later devices descend from it.

Decided: Sep 28, 2007
Review: 165 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K945802 (1995). 6 ancestors in all. 17 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
3 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
2 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
1 generation backK042729 Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005
This deviceK071056 Neutrophase Wound CleanserNovabay Pharmaceuticals · 2007
Descendant · cites it directly · 16 of its ownK081009 NeutrophaseNovabay Pharmaceuticals · 2008
Descendant · 2 generations on · 15 of its ownK113820 Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012
Descendant · 3 generations on · 8 of its ownK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014
Descendant · 4 generations on · 4 of its ownK141012 Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014
Descendant · 4 generations on · 3 of its ownK161034 Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2008high 3 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 17 · See all

K081009NeutrophaseNovabay Pharmaceuticals · 2008 · cites it directly16descendants
K113820Neutrophase Antimicrobial Wound CleanserNovabay Pharmaceuticals · 2012 · 2 generations on15descendants
K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014 · 3 generations on8descendants
K141012Hydrocleanse Wound Care SolutionOculus Innovative Sciences · 2014 · 4 generations on4descendants
K161034Microcyn Plus Wound Care SolutionOculus Innovative Sciences · 2016 · 4 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K945802	Dermagran Wound Cleanser with Zinc	Derma Sciences, Inc.	1995	—
−3	K965120	Allclenz Wound Cleanser	Dpt Laboratories, Ltd.	1997	—
−2	K022670	Carraklenz and Ultraklenz	Carrington Laboratories, Inc.	2002	—
−1	K042729	Dermacyn Wound Irrigation	Oculus Innovative Sciences, Inc.	2005	—
0 (this device)	K071056	Neutrophase Wound Cleanser	Novabay Pharmaceuticals	2007	—
+1	K081009	Neutrophase	Novabay Pharmaceuticals	2008	—
+2	K113820	Neutrophase Antimicrobial Wound Cleanser	Novabay Pharmaceuticals	2012	—
+3	K131848	Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)	Puricore, Inc.	2014	—
+4	K141012	Hydrocleanse Wound Care Solution	Oculus Innovative Sciences	2014	—
+4	K161034	Microcyn Plus Wound Care Solution	Oculus Innovative Sciences	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2012	1	0
2013	1	0
2014	3	0
2015	1	0
2016	1	0
2017	1	0
2018	1	0
2023	2	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K071056, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FRO? 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 FRO device

#1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K060113	Dermacyn Wound Care Summary page 1 …880.5090 Class 11 Predicate Devices: Device Name Manufacturer K N~umber JDermacyn Wound Oculus Innovative K(060113 Care Sciences, Inc Dermacyn Wound Oculus Innovative Irrigation S…	Oculus Innovative Sciences, Inc.	2006	—
*	K042729	Dermacyn Wound Irrigation	Oculus Innovative Sciences, Inc.	2005	—

Also cleared against K060113: 2 other devices →

What descends from it? (17)

See all 17

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081009	Neutrophase	Novabay Pharmaceuticals	2008	16

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 12 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K081009 (Novabay Pharmaceuticals, 2008) has gone furthest, with 16 descendants of its own.
2 other devices also cite its predicate K060113.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FRO

11in 2025

2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, 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	29	187	4	55
2008	26	130	1	30
2009	31	136	1	45
2010	31	146	0	122
2011	27	177	4	42
2012	24	96	0	65
2013	19	194	1	139
2014	22	214	1	269
2015	28	249	2	297
2016	28	222	3	147
2017	23	147	1	149
2018	20	206	0	128
2019	16	270	1	136
2020	12	226	0	139
2021	8	275	6	183
2022	9	332	2	176
2023	18	283	2 (2)	198
2024	24	263	2	232
2025	11	176	0	192
2026	17	254	2	—

What is it indicated for?

The device is intended for moistening absorbent wound dressings and irrigating and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening, debriding and irrigating acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree bums, abrasions and minor irritations of the skin.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071056 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071056: Neutrophase Wound Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071056

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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