510(k) Report

510(k) · Cleared

Cleared

NPD 1000 Negative Pressure Wound Therapy System

K080275510(k) TraditionalCleared Oct 9, 2008251-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

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

Cleared on Oct 9, 2008 as substantially equivalent to K063692 (Kci USA, Inc., 2007) and 1 other predicate after a 251-day review. Its family tree reaches back 4 generations to 1995. 37 later devices descend from it.

Decided
Oct 9, 2008
Review
251 days
Class
Class II
Product code
OMP
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K945062 (1995). 7 ancestors in all. 37 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor1999: 1 other ancestor2000: 1 other ancestor2011: 1 descendant cleared2012: 2 descendants cleared2014: 3 descendants cleared2017: 6 descendants cleared2016: 1 descendant cleared2024: 1 descendant cleared2021: 3 descendants cleared2023: 2 descendants cleared2018: 5 descendants cleared2020: 3 descendants cleared2019: 4 descendants cleared2022: 4 descendants cleared2026: 1 descendant cleared2025: 1 descendant clearedK945062 · Vacplus · Kinetic Concepts, Inc. · 1995K971548 · Ambuvac · Kinetic Concepts, Inc. · 1997K032310 · Mini V.a.C., V.a.C. Freedom, V.a.C. Ats · Kinetic Concepts, Inc. · 2003 · recalledK063692 · V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000 · Kci USA, Inc. · 2007 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 14 descendants4 generations forward: 10 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K063692 · V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000 · Kci USA, Inc. · 2007 · recalledK032310 · Mini V.a.C., V.a.C. Freedom, V.a.C. Ats · Kinetic Concepts, Inc. · 2003 · recalledK971548 · Ambuvac · Kinetic Concepts, Inc. · 1997K945062 · Vacplus · Kinetic Concepts, Inc. · 19950+5
  1. Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
  2. 3 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
  3. 2 generations backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
  4. 1 generation backK063692 V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc. · 2007 · Recalled
  5. This deviceK080275 NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc. · 2008
  6. Descendant · cites it directly · 26 of its ownK111170 PICOSmith & Nephew, Inc. · 2011
  7. Descendant · cites it directly · 25 of its ownK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
  8. Descendant · 2 generations on · 23 of its ownK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
  9. Descendant · 2 generations on · 11 of its ownK163387 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017
  10. Descendant · cites it directly · 9 of its ownK110078 ExtricareDevon Medical Products, Inc. · 2012

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2011: 12012: 22014: 32016: 12017: 62018: 52019: 42020: 32021: 32022: 42023: 22024: 12025: 12026: 1
2011high 6 (2017) · low 0 (2013)2026

Most influential descendants

Showing 5 of 37 · See all
  • K111170PICOSmith & Nephew, Inc. · 2011 · cites it directly26descendants
  • K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012 · cites it directly25descendants
  • K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016 · 2 generations on23descendants
  • K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017 · 2 generations on11descendants
  • K110078ExtricareDevon Medical Products, Inc. · 2012 · cites it directly9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K945062VacplusKinetic Concepts, Inc.1995—
−3K971548AmbuvacKinetic Concepts, Inc.1997—
−2K032310Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc.20032
−1K063692V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc.20071
0 (this device)K080275NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc.2008—
+1K111170PICOSmith & Nephew, Inc.2011—
+1K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc.2012—
+2K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd.2016—
+2K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited2017—
+1K110078ExtricareDevon Medical Products, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201220
201430
201610
201760
201850
201940
202030
202130
202240
202320
202410
202510
202610
FIG. 1 — Lineage of K080275, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

TypeNumberDeviceApplicantDecidedRecalls
*K063692V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000
Summary page 1
…edicate Device(s): The subject device is equivalent to the following device: *V.AC. Therapy Systems-ActiV.AC. Therapy Unit M: K063692 *Boehringer Laboratories Suction Pump System: K060277 Device Description: The NPD 100…
Kci USA, Inc.20071
*K060277Boehringer Laboratories Suction Pump System
Summary page 1
…*V.AC. Therapy Systems-ActiV.AC. Therapy Unit M: K063692 *Boehringer Laboratories Suction Pump System: K060277 Device Description: The NPD 1000 Negative Pressure Wound Therapy System includes a small, p…
Boehringer Laboratories2006—

Also cleared against K063692: 3 other devices →

What descends from it? (37)

See all 37

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

NumberDeviceApplicantDecidedDescendants
K111170PICOSmith & Nephew, Inc.201126
K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc.201225
K110078ExtricareDevon Medical Products, Inc.20129
K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140

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 13 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K111170 (Smith & Nephew, Inc., 2011) has gone furthest, with 26 descendants of its own.
  • 3 other devices also cite its predicate K063692.

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. 2008, this device’s year, is highlighted.

FDA decisions per year · OMP

5in 2025

2007: 62008: 82009: 82010: 62011: 62012: 112013: 112014: 102015: 202016: 192017: 112018: 132019: 152020: 62021: 92022: 102023: 82024: 92025: 52026 (partial year): 9
2007high 20 (2015) · low 5 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMP

127in 2025

2007: 113 days median2008: 98 days median2009: 87 days median2010: 97 days median2011: 123 days median2012: 292 days median2013: 84 days median2014: 179 days median2015: 189 days median2016: 146 days median2017: 137 days median2018: 214 days median2019: 249 days median2020: 179 days median2021: 238 days median2022: 229 days median2023: 291 days median2024: 181 days median2025: 127 days median2026 (partial year): 141 days median
2007high 292 (2012) · low 84 (2013)2026

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

Recalls per year · OMP

2in 2024

2009: 72010: 32012: 12013: 22014: 42015: 12016: 22019: 12024: 2
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

2007: 12008: 12009: 792010: 802011: 1302012: 972013: 1692014: 2292015: 3782016: 3982017: 3682018: 4222019: 9942020: 3,6642021: 1,4222022: 2582023: 1432024: 1352025: 140
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007611301
200889801
2009887779
2010697380
201161230130
201211292197
201311842169
2014101794229
2015201891378
2016191462398
2017111370368
2018132140422
2019152491994
2020617903,664
2021923801,422
2022102290258
202382910143
202491812135
202551270140
202691410—

What is it indicated for?

The NPD 1000 Negative Pressure Wound Therapy System is a portable, low-powered,

battery-operated suction pump intended for the application of suction to remove a small

amount of fluid from the wound bed including wound exudate and infectious material

which may promote wound healing.

Indications for use as stated in the FDA summary.

Also cleared against K063692

3 other devices cite the same predicate.

  • K183543ACTIV.A.C. Therapy UnitKci USA, Inc. · 20191 recall
  • K113236Foryou NPWT DeviceForyou Medical Electronics Co, Ltd. · 2013
  • K093526V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C. Via Dressing (Containing V.a.C.…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010

Recent decisions in OMP

The OMP category page

  • K261982RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)Smith & Nephew Medical, Ltd. · 2026
  • K260426MeCare Alpha (MCA2019)IVT Medical, Ltd. · 2026
  • K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026
  • K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building · 2026
  • K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd. · 2026

https://510kreport.com/device/K080275 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080275: NPD 1000 Negative Pressure Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080275

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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