510(k) Report

510(k) · Cleared

Cleared

Life-Air 1000 Hypothermic Therapy System

K952329510(k) TraditionalCleared Jan 17, 1996244-day reviewClass II21 CFR 870.5900

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

Progressive Dynamics, Inc. · DWJ System, Thermal Regulating

Cleared on Jan 17, 1996 after a 244-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jan 17, 1996
Review
244 days
Class
Class II
Product code
DWJ
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2008: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952329 Life-Air 1000 Hypothermic Therapy SystemProgressive Dynamics, Inc. · 1996
  2. Descendant · cites it directly · 1 of its ownK071918 Chillbuster Portable Electric Blanket, Model 8002Thermogear, Inc. · 2007
  3. Descendant · 2 generations on · 0 of its ownK083135 Modification to Chillbuster Portable Electric Blanket , Model 8002Thermogear, Inc. · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K071918Chillbuster Portable Electric Blanket, Model 8002Thermogear, Inc. · 2007 · cites it directly1descendant
  • K083135Modification to Chillbuster Portable Electric Blanket , Model 8002Thermogear, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952329Life-Air 1000 Hypothermic Therapy SystemProgressive Dynamics, Inc.1996—
+1K071918Chillbuster Portable Electric Blanket, Model 8002Thermogear, Inc.2007—
+2K083135Modification to Chillbuster Portable Electric Blanket , Model 8002Thermogear, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
FIG. 1 — Lineage of K952329, 1996–2008Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DWJ? 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 DWJ device

  1. #1 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 5 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K071918Chillbuster Portable Electric Blanket, Model 8002Thermogear, Inc.20071

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?

  • Of its descendants, K071918 (Thermogear, Inc., 2007) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DWJ devices

DWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWJ

3in 2025

2007: 42008: 32009: 32010: 82011: 42012: 52013: 52014: 42016: 22017: 52018: 32019: 22020: 52021: 22022: 22023: 62024: 22025: 32026 (partial year): 5
2007high 8 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWJ

131in 2025

2007: 106 days median2008: 73 days median2009: 106 days median2010: 134 days median2011: 180 days median2012: 69 days median2013: 77 days median2014: 131 days median2017: 153 days median2018: 95 days median2020: 30 days median2023: 42 days median2025: 131 days median2026 (partial year): 99 days median
2007high 180 (2011) · low 30 (2020)2026

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

Recalls per year · DWJ

3in 2024

2009: 62010: 22011: 72012: 12013: 22015: 12017: 32018: 52019: 32020: 22021: 12022: 52024: 32026 (partial year): 3
2007high 7 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DWJ

2,384in 2025

2007: 522008: 402009: 712010: 1042011: 1362012: 1062013: 732014: 1162015: 2452016: 1,4002017: 1,4732018: 1,5172019: 2,2942020: 2,5462021: 2,6892022: 3,2262023: 3,4552024: 3,3292025: 2,384
2007high 3,455 (2023) · low 40 (2008)2025

MAUDE reports naming product code DWJ, 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
20074106052
2008373040
20093106671
201081342104
201141807136
20125691106
2013577273
201441310116
20150—1245
20162—01,400
2017515331,473
201839551,517
20192—32,294
202053022,546
20212—12,689
20222—53,226
202364203,455
20242—33,329
2025313102,384
20265993—

More from Progressive Dynamics, Inc.

7 FDA decisions under this applicant name. See the company

  • K944688Luminous 150 Dual Lampfiberoptic IlluminatorProgressive Dynamics, Inc. · 1994
  • K933764Life-Air 1000 Patient Warming CoverProgressive Dynamics, Inc. · 1993
  • K933593Luminous 150 Fiberoptic IlluminatorProgressive Dynamics, Inc. · 1993
  • K921866Luminous 250 Fiberoptic IlluminatorProgressive Dynamics, Inc. · 1992
  • K914382Life-Air 1000 Hypothermic Treatment SystemProgressive Dynamics, Inc. · 1992

Recent decisions in DWJ

The DWJ category page

  • K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd. · 2026
  • K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life · 2026
  • K260278ThermAffyx (TM) Patient Safety SystemStihler Electronic GmbH · 2026
  • K260903Hot Pink Pad Warming SystemXodus Medical, Inc. · 2026
  • K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K952329 · printed Nov 5, 2026

Cite this page

510(k) Report. “K952329: Life-Air 1000 Hypothermic Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952329

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026