510(k) · Cleared

Cleared

USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles

K161311510(k) TraditionalCleared Aug 29, 2016111-day reviewClass U

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

Strukmyer Medical, LLC · FRO Dressing, Wound, Drug

Cleared on Aug 29, 2016 as substantially equivalent to K083042 (Nurse Assist, Inc., 2008) after a 111-day review. Its family tree reaches back 6 generations to 1995. 1 of the 20 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: Aug 29, 2016
Review: 111 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 1

Its longest line of descent runs back 6 generations to K945802 (1995). 17 ancestors in all, the oldest K935060 (1994). 2 later devices descend from it, 1 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 6 generations backK945802 Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 1995
5 generations backK965120 Allclenz Wound CleanserDpt Laboratories, Ltd. · 1997
4 generations backK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
3 generations backK040779 Restore Wound CleanserHollister, Inc. · 2004
2 generations backK042084 Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005
1 generation backK083042 Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · Recalled (Class I)
This deviceK161311 USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9%…Strukmyer Medical, LLC · 2016
Descendant · cites it directly · 1 of its ownK172486 Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline…Anexa Biomedical, Inc. · 2017
Descendant · 2 generations on · 0 of its ownK181423 AMSure Sterile Water, and Sterile Normal Saline for Wound FlushAmsino International, Inc. · 2018

Class I recalls in this family

K083042 Wound Flush, Sterile Water & Normal Salinedirect predicate · 2008

Most influential descendants

Showing 2 of 2 · See all

K172486Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium…Anexa Biomedical, Inc. · 2017 · cites it directly1descendant
K181423AMSure Sterile Water, and Sterile Normal Saline for Wound FlushAmsino International, Inc. · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K945802	Dermagran Wound Cleanser with Zinc	Derma Sciences, Inc.	1995	—
−5	K965120	Allclenz Wound Cleanser	Dpt Laboratories, Ltd.	1997	—
−4	K022670	Carraklenz and Ultraklenz	Carrington Laboratories, Inc.	2002	—
−3	K040779	Restore Wound Cleanser	Hollister, Inc.	2004	—
−2	K042084	Bioderm Sciences Wound Healing Spray	Bioderm Sciences, Inc.	2005	—
−1	K083042	Wound Flush, Sterile Water & Normal Saline	Nurse Assist, Inc.	2008	Class I
0 (this device)	K161311	USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium…	Strukmyer Medical, LLC	2016	—
+1	K172486	Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9%…	Anexa Biomedical, Inc.	2017	—
+2	K181423	AMSure Sterile Water, and Sterile Normal Saline for Wound Flush	Amsino International, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1995	1	0
1998	1	0
1999	1	0
2001	1	0
2004	1	0
2005	2	0
2006	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2018	1	0

FIG. 1 — Lineage of K161311, 1995–2018Source: 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.

1 device in this family has a Class I recall. 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? (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	Applicant	Decided	Recalls
*	K083042	Wound Flush, Sterile Water & Normal Saline Summary page 4 …le Normal Saline Classification Name: Unclassified, pre-amendment device; Product Code FRO III. PREDICATE DEVICE Sterile Water and Sterile Normal Saline ; K083042, Nurse Assist, Inc. IV. DEVICE DESCRIPTION The Sterile Water and Sterile Normal Saline devices are wound and device cle…	Nurse Assist, Inc.	2008	Class I

Also cleared against K083042: 5 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K172486	Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium…	Anexa Biomedical, Inc.	2017	1

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 3.5 years on median.
2 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K172486 (Anexa Biomedical, Inc., 2017) has gone furthest, with 1 descendant of its own.
5 other devices also cite its predicate K083042.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?

For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.

For Prescription Use: For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K161311 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161311: USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161311

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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