510(k) Report

510(k) · Cleared

Cleared

Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900

K100585510(k) TraditionalCleared Jan 20, 2011324-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

Gaymar Industries, Inc. · DWJ System, Thermal Regulating

Cleared on Jan 20, 2011 as substantially equivalent to K912051 (Gaymar Industries, Inc., 1991) and 4 other predicates after a 324-day review. Its family tree reaches back 3 generations to 1991. 9 later devices descend from it.

Decided
Jan 20, 2011
Review
324 days
Class
Class II
Product code
DWJ
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K912051 (1991). 9 ancestors in all, the oldest K811742 (1981). 9 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2007: 1 other ancestor2000: 1 other ancestor2003: 1 other ancestor2001: 1 other ancestor1981: 1 other ancestor2014: 1 descendant cleared2016: 2 descendants cleared2017: 1 descendant cleared2025: 3 descendants cleared2018: 1 descendant cleared2020: 1 descendant clearedK912051 · Medi-Therm (Mta-5900) & Detachable Hoses · Gaymar Industries, Inc. · 1991 · recalledK061023 · Thermosuit System · Life Recovery Systems Hd, LLC · 2006 · recalledK070112 · Rapidcool Patient Temperature Management System · Medcool, Inc. · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K070112 · Rapidcool Patient Temperature Management System · Medcool, Inc. · 2007K061023 · Thermosuit System · Life Recovery Systems Hd, LLC · 2006 · recalledK912051 · Medi-Therm (Mta-5900) & Detachable Hoses · Gaymar Industries, Inc. · 1991 · recalled0
  1. Root · 3 generations backK912051 Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc. · 1991 · Recalled
  2. 2 generations backK061023 Thermosuit SystemLife Recovery Systems Hd, LLC · 2006 · Recalled
  3. 1 generation backK070112 Rapidcool Patient Temperature Management SystemMedcool, Inc. · 2007
  4. This deviceK100585 Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011
  5. Descendant · cites it directly · 4 of its ownK142702 Arctic Sun Temperature Management System, ArcticGel Pads (Universal…Medivance, Inc. · 2014 · Recalled
  6. Descendant · cites it directly · 3 of its ownK152266 Altrix Precision Temperature Management SystemStryker Medical · 2016 · Recalled
  7. Descendant · 2 generations on · 3 of its ownK161602 Arctic Sun Temperature Management SystemMedivance, Inc. · 2016 · Recalled
  8. Descendant · 3 generations on · 1 of its ownK200225 Arctic Sun Stat Temperature Management SystemMedivance, Inc. · 2020 · Recalled
  9. Descendant · 3 generations on · 0 of its ownK251974 Arctic Sun Temperature Management System (Model 5000)Medivance, Inc. · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2014: 12016: 22017: 12018: 12020: 12025: 3
2014high 3 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · See all
  • K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc. · 2014 · cites it directly4descendants
  • K152266Altrix Precision Temperature Management SystemStryker Medical · 2016 · cites it directly3descendants
  • K161602Arctic Sun Temperature Management SystemMedivance, Inc. · 2016 · 2 generations on3descendants
  • K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc. · 2020 · 3 generations on1descendant
  • K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K912051Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc.19912
−2K061023Thermosuit SystemLife Recovery Systems Hd, LLC20061
−1K070112Rapidcool Patient Temperature Management SystemMedcool, Inc.2007—
0 (this device)K100585Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc.2011—
+1K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS…Medivance, Inc.20146
+1K152266Altrix Precision Temperature Management SystemStryker Medical20161
+2K161602Arctic Sun Temperature Management SystemMedivance, Inc.20162
+3K200225Arctic Sun Stat Temperature Management SystemMedivance, Inc.20201
+3K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
200010
200110
200310
200710
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201620
201710
201810
202010
202530
FIG. 1 — Lineage of K100585, 1991–2025Source: 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 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 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? (5)

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
*K912051Medi-Therm (Mta-5900) & Detachable Hoses
Summary page 1
…DWJ PREDICATE DEVICES Gaymar Industries Inc. ("Gaymar") claims substantial equivalence to: I. Gaymar Industries Inc. Medi-Therm System MTA5900 (K9 1205 1) 2. MedCool Inc. RapidCoolTM Patient Temperature Management System, (K0701 12) 3. Medivance ArcticSun Temperature Managemen…
Gaymar Industries, Inc.19912
*K070112Rapidcool Patient Temperature Management System
Summary page 1
…ms substantial equivalence to: I. Gaymar Industries Inc. Medi-Therm System MTA5900 (K9 1205 1) 2. MedCool Inc. RapidCoolTM Patient Temperature Management System, (K0701 12) 3. Medivance ArcticSun Temperature Management System (K071341) 4. M.T.R.E. Advanced Technology Ltd. CritiCool System (K083…
Medcool, Inc.2007—
*K071341Modification to Arctic Sun Temperature Management System, Model 2000
Summary page 1
…herm System MTA5900 (K9 1205 1) 2. MedCool Inc. RapidCoolTM Patient Temperature Management System, (K0701 12) 3. Medivance ArcticSun Temperature Management System (K071341) 4. M.T.R.E. Advanced Technology Ltd. CritiCool System (K083662) 5. M.T.R.E. Advanced Technology Ltd. Allon 2001 System (K0…
Medivance, Inc.20071
*K083662Criticool
Summary page 1
…ent Temperature Management System, (K0701 12) 3. Medivance ArcticSun Temperature Management System (K071341) 4. M.T.R.E. Advanced Technology Ltd. CritiCool System (K083662) 5. M.T.R.E. Advanced Technology Ltd. Allon 2001 System (K003349) DEVICE DESCRIPTION The Gaymar Medi-Therm. device provides…
Mtre Advanced Technology, Ltd.20091
*K003349Allon 2001 Modified
Summary page 1
…Sun Temperature Management System (K071341) 4. M.T.R.E. Advanced Technology Ltd. CritiCool System (K083662) 5. M.T.R.E. Advanced Technology Ltd. Allon 2001 System (K003349) DEVICE DESCRIPTION The Gaymar Medi-Therm. device provides a means of regulating patient temperature by supplying temperature-…
Mtre Advanced Technology, Ltd.2000—

Also cleared against K912051: 4 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…Medivance, Inc.20144
K152266Altrix Precision Temperature Management SystemStryker Medical20163

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 20 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
  • 7 of the 9 ancestors have a recall of any class.
  • Of its descendants, K142702 (Medivance, Inc., 2014) has gone furthest, with 4 descendants of its own.
  • 4 other devices also cite its predicate K912051.

How does its category compare?

All DWJ devices

DWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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—

What is it indicated for?

The Medi-Therm is intended for use in supplying warm or cold water at controlled temperatures via water circulating blankets or body wraps for the application of regulating patient temperature in situations where a physician determines that temperature therapy is necessary and desirable. Indications for use for the Medi-Therm thermal regulating system include: a. To maintain pre-set body temperature as determined by the physician b. To maintain normal…

Read the full statement (127 words)

The Medi-Therm is intended for use in supplying warm or cold water at controlled temperatures via water circulating blankets or body wraps for the application of regulating patient temperature in situations where a physician determines that temperature therapy is necessary and desirable.

Indications for use for the Medi-Therm thermal regulating system include:

a. To maintain pre-set body temperature as determined by the physician

b. To maintain normal body temperature during surgical procedures

c. For use in all hospital areas including invasive and coronary care units, in operating, recovery and emergency rooms, in burn units and on medical/surgical floors

d. This system can be used with adult and pediatric patients

e. Monitoring and controlling patient temperature

f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients

Indications for use as stated in the FDA summary.

Also cleared against K912051

4 other devices cite the same predicate.

  • K101589Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc. · 20106 recalls
  • K071341Modification to Arctic Sun Temperature Management System, Model 2000Medivance, Inc. · 20071 recall
  • K061023Thermosuit SystemLife Recovery Systems Hd, LLC · 20061 recall
  • K022366Celsius Control SystemInnercool Therapies · 2003

More from Gaymar Industries, Inc.

27 FDA decisions under this applicant name. See the company

  • K073675T-Pump Localized Temperature Therapy PumpGaymar Industries, Inc. · 20081 recall
  • K962788Clinidyne Rotational Therapy Mattress SystemGaymar Industries, Inc. · 1997
  • K963067Sof. Press Epc 51 SystemGaymar Industries, Inc. · 1997
  • K961854SPR Plus II Overlay System (CL250/CL212Gaymar Industries, Inc. · 1996
  • K942881TC 3000Gaymar Industries, Inc. · 1995

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/K100585 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100585: Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100585

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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