510(k) · Cleared

Cleared

Genadyne ASTRA NPWT

K253429510(k) TraditionalCleared Mar 12, 2026162-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

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

Cleared on Mar 12, 2026 as substantially equivalent to K210107 (Genadyne Biotechnologies, Inc., 2022) after a 162-day review. Its family tree reaches back 1 generation to 2022.

Decided: Mar 12, 2026
Review: 162 days
Class: Class II
Product code: OMP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K210107 (2022). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK210107 Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2022
This deviceK253429 Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc. · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K210107	Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System	Genadyne Biotechnologies, Inc.	2022	—
0 (this device)	K253429	Genadyne ASTRA NPWT	Genadyne Biotechnologies, Inc.	2026	—

FIG. 1 — Lineage of K253429, 2022–2026Source: 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 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
*	K210107	Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System Summary page 5 …Pump Product Code OMP Classification Class II Panel General and Plastic Surgery Predicate Device Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System, K210107 Device Description The Genadyne ASTRA NPWT is a Negative Pressure Wound Therapy. The ASTRA NPWT features an interface touch pan…	Genadyne Biotechnologies, Inc.	2022	—

Also cleared against K210107: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
1 other device also cites its predicate K210107.

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. 2026, 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?

Genadyne Astra NPWT System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device can be used for wound management by the removal of excess exudates, infectious material and tissue debris.

Appropriate wound type include:

- Chronic

- Acute

- Traumatic

- Subacute and dehisced wounds

- Partial thickness burns

- Ulcers (such as diabetic or pressure)

- Flaps and grafts

For use by healthcare professional and home use. This NPWT System can only be used with approved dressing kits under K233614.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K253429 · printed Nov 4, 2026

Cite this page

510(k) Report. “K253429: Genadyne ASTRA NPWT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253429

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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