510(k) · Cleared

Cleared

Atmos S041 Wound

K090130510(k) TraditionalCleared Apr 2, 200971-day reviewClass II21 CFR 878.4780

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

Atmos, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on Apr 2, 2009 as substantially equivalent to K061367 (Blue Sky Medical Group Incorporated, 2006) after a 71-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.

Decided: Apr 2, 2009
Review: 71 days
Class: Class II
Product code: OMP
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K945062 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
3 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
2 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
1 generation backK061367 Bluesky Vista Wound Vacuum System, Model 100.0500Blue Sky Medical Group Incorporated · 2006
This deviceK090130 Atmos S041 WoundAtmos, Inc. · 2009
Descendant · cites it directly · 0 of its ownK142385 Whisper Pump SystemWound RX Medical, LLC · 2015

Most influential descendants

Showing 1 of 1 · See all

K142385Whisper Pump SystemWound RX Medical, LLC · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K945062	Vacplus	Kinetic Concepts, Inc.	1995	—
−3	K042134	Versatile 1 Wound Vacuum System	Blue Sky Medical Group Incorporated	2004	2
−2	K052456	Modification to Versatile 1 Wound Vacuum System	Blue Sky Medical Group Incorporated	2005	—
−1	K061367	Bluesky Vista Wound Vacuum System, Model 100.0500	Blue Sky Medical Group Incorporated	2006	—
0 (this device)	K090130	Atmos S041 Wound	Atmos, Inc.	2009	—
+1	K142385	Whisper Pump System	Wound RX Medical, LLC	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K090130, 1995–2015Source: 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 OMP? 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 OMP device

#1 K260646 Renasys Edge (66803126)score 15.3 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K061367	Bluesky Vista Wound Vacuum System, Model 100.0500 Summary page 1 …878.4780, Class II Product Code: "- - Predicate Device: 21 CFR 807. 92(a)(3) 510(k) Number K061367 Device Name BlueSky VISTA TM Wound Vacuum System Applicant…	Blue Sky Medical Group Incorporated	2006	—

Also cleared against K061367: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K142385	Whisper Pump System	Wound RX Medical, LLC	2015	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?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K142385 (Wound RX Medical, LLC, 2015) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K061367.

How does its category compare?

All OMP devices

OMP Negative Pressure Wound Therapy Powered Suction Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · OMP

5in 2025

2007high 20 (2015) · low 5 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMP

127in 2025

2007high 292 (2012) · low 84 (2013)2026

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

Recalls per year · OMP

2in 2024

2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OMP

140in 2025

2007high 3,664 (2020) · low 1 (2007)2025

MAUDE reports naming product code OMP, 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	6	113	0	1
2008	8	98	0	1
2009	8	87	7	79
2010	6	97	3	80
2011	6	123	0	130
2012	11	292	1	97
2013	11	84	2	169
2014	10	179	4	229
2015	20	189	1	378
2016	19	146	2	398
2017	11	137	0	368
2018	13	214	0	422
2019	15	249	1	994
2020	6	179	0	3,664
2021	9	238	0	1,422
2022	10	229	0	258
2023	8	291	0	143
2024	9	181	2	135
2025	5	127	0	140
2026	9	141	0	—

What is it indicated for?

The ATMOS S041 WoundTM is a suction device intended for aspiration and collection of secretions and body fluids from wounds and is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. ATMOS S041 is appropriate for use on the following wounds: * Pressure ulcers * Diabetic/neuropathic ulcers * Venous insufficiency ulcers * Traumatic wounds * Post-operative and dehisced surgical wounrds *…

Read the full statement (171 words)

The ATMOS S041 WoundTM is a suction device intended for aspiration and collection of

secretions and body fluids from wounds and is indicated for patients who would benefit from a

suction device particularly as the device may promote wound healing. ATMOS S041 is

appropriate for use on the following wounds:

* Pressure ulcers

* Diabetic/neuropathic ulcers

* Venous insufficiency ulcers

* Traumatic wounds

* Post-operative and dehisced surgical wounrds

* Explored fistulas

* Skin flaps and grafts

Contraindications

The use of the ATMOS S 041 WOUND is contraindicated in the presence of:

*Eschar

· Untreated osteomyelitis

* Malignancy in wound (with exception of palliative care to enhance quality of life)

* Untreated malnutrition

* Exposed arteries, veins or organs

*Necrotic tissue

*Non-enteric unexplored fistulas

* Exposed nerves

* Exposed anastomotic site

* Exposed bone or tendons

* Exposed vasculature

The ATMOS S 041 WOUND is not designed for use with emergency medical services.

Not to be used:

* In non-medical applications

* In presence of combustible or explosive fluids or gases

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090130 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090130: Atmos S041 Wound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090130

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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