510(k) Report

510(k) · Cleared

Cleared

Antlia II Suction Pump System

K070904510(k) TraditionalCleared Apr 13, 200711-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

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

Cleared on Apr 13, 2007 as substantially equivalent to K061435 (Medela AG, 2006) and 1 other predicate after an 11-day review. Its family tree reaches back 3 generations to 1995. 109 later devices descend from it.

Decided
Apr 13, 2007
Review
11 days
Class
Class II
Product code
OMP
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K945062 (1995). 5 ancestors in all. 109 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor1999: 1 other ancestor2009: 2 descendants cleared2011: 4 descendants cleared2008: 1 descendant cleared2014: 8 descendants cleared2013: 4 descendants cleared2010: 2 descendants cleared2016: 13 descendants cleared2012: 5 descendants cleared2015: 12 descendants cleared2017: 9 descendants cleared2024: 4 descendants cleared2021: 5 descendants cleared2023: 4 descendants cleared2019: 10 descendants cleared2025: 4 descendants cleared2018: 7 descendants cleared2022: 7 descendants cleared2020: 3 descendants cleared2026: 5 descendants clearedK945062 · Vacplus · Kinetic Concepts, Inc. · 1995K042134 · Versatile 1 Wound Vacuum System · Blue Sky Medical Group Incorporated · 2004 · recalledK052456 · Modification to Versatile 1 Wound Vacuum System · Blue Sky Medical Group Incorporated · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 12 descendants3 generations forward: 26 descendants4 generations forward: 33 descendants5 generations forward: 26 descendants6 generations forward: 6 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant K052456 · Modification to Versatile 1 Wound Vacuum System · Blue Sky Medical Group Incorporated · 2005K042134 · Versatile 1 Wound Vacuum System · Blue Sky Medical Group Incorporated · 2004 · recalledK945062 · Vacplus · Kinetic Concepts, Inc. · 19950+5
  1. Root · 3 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
  2. 2 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
  3. 1 generation backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
  4. This deviceK070904 Antlia II Suction Pump SystemInnovative Therapies, Inc. · 2007
  5. Descendant · cites it directly · 68 of its ownK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
  6. Descendant · cites it directly · 56 of its ownK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
  7. Descendant · 2 generations on · 48 of its ownK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
  8. Descendant · 2 generations on · 31 of its ownK092992 A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010
  9. Descendant · 2 generations on · 26 of its ownK111170 PICOSmith & Nephew, Inc. · 2011

Showing 5 of 109 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22010: 22011: 42012: 52013: 42014: 82015: 122016: 132017: 92018: 72019: 102020: 32021: 52022: 72023: 42024: 42025: 42026: 5
2008high 13 (2016) · low 1 (2008)2026

Most influential descendants

Showing 5 of 109 · See all
  • K082211Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · cites it directly68descendants
  • K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · cites it directly56descendants
  • K110647Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…Smith & Nephew, Inc. · 2011 · 2 generations on48descendants
  • K092992A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010 · 2 generations on31descendants
  • K111170PICOSmith & Nephew, Inc. · 2011 · 2 generations on26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K945062VacplusKinetic Concepts, Inc.1995—
−2K042134Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated20042
−1K052456Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated2005—
0 (this device)K070904Antlia II Suction Pump SystemInnovative Therapies, Inc.2007—
+1K082211Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc.20081
+1K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc.20092
+2K110647Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT…Smith & Nephew, Inc.20116
+2K092992A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc.2010—
+2K111170PICOSmith & Nephew, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201020
201140
201250
201340
201480
2015120
2016130
201790
201870
2019100
202030
202150
202270
202340
202440
202540
202650
FIG. 1 — Lineage of K070904, 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
*K061435Medela Vario Suction Pumps
Summary page 1
…21 CFR 878.4780 Class II 6. Predicate Device: Medela InviaTM Healing System, K061435 BlueSky Medical Versatile LTM Wound Vacuum System…
Medela AG2006—
*K052456Modification to Versatile 1 Wound Vacuum System
Summary page 1
…Medela InviaTM Healing System, K061435 BlueSky Medical Versatile LTM Wound Vacuum System, K052456 7. Description of Device The ANTLIA HPM Suction Pump System, an AC-powered, portable suction device with battery ba…
Blue Sky Medical Group Incorporated2005—

Also cleared against K061435: 2 other devices →

What descends from it? (109)

See all 109

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

NumberDeviceApplicantDecidedDescendants
K082211Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc.200868
K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc.200956
K111333Antlia Iii Wound Treatment SystemInnovative Therapies, Inc.20115

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 12 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K082211 (Smith & Nephew, Inc., 2008) has gone furthest, with 68 descendants of its own.
  • 2 other devices also cite its predicate K061435.

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. 2007, 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 ANTLIA Ifl'M Suction Pump System is indicated for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.

Indications for use as stated in the FDA summary.

Also cleared against K061435

2 other devices cite the same predicate.

  • K153663Vario 8/18/ciMedela AG · 2016
  • K093261MOVESThornhill Research, Inc. · 20102 Class I recalls

More from Innovative Therapies, Inc.

4 FDA decisions under this applicant name. See the company

  • K111333Antlia Iii Wound Treatment SystemInnovative Therapies, Inc. · 2011
  • K093564Sved Wound Treatment SystemInnovative Therapies, Inc. · 2009
  • K071301Antlia I Wound Irrigation SystemInnovative Therapies, Inc. · 2007

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/K070904 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070904: Antlia II Suction Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070904

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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