510(k) Report

510(k) · Cleared

Cleared

Bluesky Vista Wound Vacuum System, Model 100.0500

K061367510(k) TraditionalCleared Aug 10, 200686-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

Blue Sky Medical Group Incorporated · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on Aug 10, 2006 as substantially equivalent to K042134 (Blue Sky Medical Group Incorporated, 2004) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1995. 24 later devices descend from it.

Decided
Aug 10, 2006
Review
86 days
Class
Class II
Product code
OMP
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K945062 (1995). 4 ancestors in all. 24 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor2009: 2 descendants cleared2011: 1 descendant cleared2008: 1 descendant cleared2014: 5 descendants cleared2015: 2 descendants cleared2016: 1 descendant cleared2019: 1 descendant cleared2024: 2 descendants cleared2021: 3 descendants cleared2023: 2 descendants cleared2025: 1 descendant cleared2017: 1 descendant cleared2026: 1 descendant cleared2022: 1 descendant 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 2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 10 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants 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 deviceK061367 Bluesky Vista Wound Vacuum System, Model 100.0500Blue Sky Medical Group Incorporated · 2006
  5. Descendant · cites it directly · 11 of its ownK082676 Genadyne A4 Wound Vacuum SystemGenadyne Biotechnologies, Inc. · 2008
  6. Descendant · cites it directly · 10 of its ownK100823 Wound Pro ApexAccuro Medical Products, LLC · 2011 · Recalled
  7. Descendant · 2 generations on · 8 of its ownK132225 ExtricareDevon Medical, Inc. · 2014
  8. Descendant · 2 generations on · 5 of its ownK140022 Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister…Cork Medical Products, LLC · 2014
  9. Descendant · 3 generations on · 4 of its ownK140634 extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and…Devon Medical, Inc. · 2014

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22011: 12014: 52015: 22016: 12017: 12019: 12021: 32022: 12023: 22024: 22025: 12026: 1
2008high 5 (2014) · low 0 (2010)2026

Most influential descendants

Showing 5 of 24 · See all
  • K082676Genadyne A4 Wound Vacuum SystemGenadyne Biotechnologies, Inc. · 2008 · cites it directly11descendants
  • K100823Wound Pro ApexAccuro Medical Products, LLC · 2011 · cites it directly10descendants
  • K132225ExtricareDevon Medical, Inc. · 2014 · 2 generations on8descendants
  • K140022Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT…Cork Medical Products, LLC · 2014 · 2 generations on5descendants
  • K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc. · 2014 · 3 generations on4descendants
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)K061367Bluesky Vista Wound Vacuum System, Model 100.0500Blue Sky Medical Group Incorporated2006—
+1K082676Genadyne A4 Wound Vacuum SystemGenadyne Biotechnologies, Inc.2008—
+1K100823Wound Pro ApexAccuro Medical Products, LLC20111
+2K132225ExtricareDevon Medical, Inc.2014—
+2K140022Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus…Cork Medical Products, LLC2014—
+3K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT…Devon Medical, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201110
201450
201520
201610
201710
201910
202130
202210
202320
202420
202510
202610
FIG. 1 — Lineage of K061367, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
*K042134Versatile 1 Wound Vacuum System
Summary page 1
…21 CFR 878.4780, Product Code BTA) Predicate Device Information Versatile LTM Wound Vacuum System cleared originally in K042134 (November 15, 2004) and amended in K052456 (November 4, 2005). Product Description The product is a portable suction pump that ma…
Blue Sky Medical Group Incorporated20042
*K052456Modification to Versatile 1 Wound Vacuum System
Summary page 1
…878.4780, Product Code BTA) Predicate Device Information Versatile LTM Wound Vacuum System cleared originally in K042134 (November 15, 2004) and amended in K052456 (November 4, 2005). Product Description The product is a portable suction pump that may promote wound healing when used with acce…
Blue Sky Medical Group Incorporated2005—

Also cleared against K042134: 9 other devices →

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K082676Genadyne A4 Wound Vacuum SystemGenadyne Biotechnologies, Inc.200811
K100823Wound Pro ApexAccuro Medical Products, LLC201110
K090130Atmos S041 WoundAtmos, Inc.20091

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 11 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K082676 (Genadyne Biotechnologies, Inc., 2008) has gone furthest, with 11 descendants of its own.
  • 9 other devices also cite its predicate K042134.

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.

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 BlueSky VISTA™ Wound Vacuum System is indicated for patients who

would benefit from a suction device particularly as the device may promote

wound healing.

Indications for use as stated in the FDA 510(k) statement.

Also cleared against K042134

9 other devices cite the same predicate.

  • K113291Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and Sim-EX300Simex Medizintechnik GmbH · 2012
  • K110647Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound Dressing Kits with Suction…Smith & Nephew, Inc. · 20116 recalls
  • K080897Venturi Negative Pressure Wound Therapy SystemTalley Medical · 2008
  • K061919Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 20071 recall
  • K062456Novaspine Powered Suction Pump Pro-1Novaspine, LLC · 2006
  • K061788Boehringer Laboratories Suction Pump SystemBoehringer Laboratories · 20065 recalls

More from Blue Sky Medical Group Incorporated

4 FDA decisions under this applicant name. See the company

  • K061919Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 20071 recall
  • K052456Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
  • K042134Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 20042 recalls

Recent decisions in OMP

The OMP category page

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  • K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building · 2026
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https://510kreport.com/device/K061367 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061367: Bluesky Vista Wound Vacuum System, Model 100.0500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061367

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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