510(k) · Cleared

Cleared

Wet Dressing Saline-Sterile

K844096510(k) TraditionalCleared Nov 19, 198427-day reviewClass U

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

Absorbent Cotton Co., Inc. · FRO Dressing, Wound, Drug

Cleared on Nov 19, 1984 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Nov 19, 1984
Review: 27 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK844096 Wet Dressing Saline-SterileAbsorbent Cotton Co., Inc. · 1984
Descendant · cites it directly · 0 of its ownK940076 Dermassist Wet Dressing, WaterWilshire Medical Products · 1994
Descendant · cites it directly · 0 of its ownK940044 Dermassist Wet Dressing, SalineWilshire Medical Products · 1994

Most influential descendants

Showing 2 of 2 · See all

K940076Dermassist Wet Dressing, WaterWilshire Medical Products · 1994 · cites it directly0descendants
K940044Dermassist Wet Dressing, SalineWilshire Medical Products · 1994 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K844096	Wet Dressing Saline-Sterile	Absorbent Cotton Co., Inc.	1984	—
+1	K940076	Dermassist Wet Dressing, Water	Wilshire Medical Products	1994	—
+1	K940044	Dermassist Wet Dressing, Saline	Wilshire Medical Products	1994	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0

FIG. 1 — Lineage of K844096, 1984–1994Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K940076	Dermassist Wet Dressing, Water	Wilshire Medical Products	1994	0
K940044	Dermassist Wet Dressing, Saline	Wilshire Medical Products	1994	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, K940076 (Wilshire Medical Products, 1994) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FRO devices

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

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	—

https://510kreport.com/device/K844096 · printed Nov 4, 2026

Cite this page

510(k) Report. “K844096: Wet Dressing Saline-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K844096

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026