510(k) · Cleared

Cleared

Palmo Thermoregulation Interface Accessory

K014210510(k) TraditionalCleared Aug 16, 2002238-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

Avacore Technologies, Inc. · DWJ System, Thermal Regulating

Cleared on Aug 16, 2002 as substantially equivalent to K970376 (Lake Region Mfg., Inc., 1997) after a 238-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Aug 16, 2002
Review: 238 days
Class: Class II
Product code: DWJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970376 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
This deviceK014210 Palmo Thermoregulation Interface AccessoryAvacore Technologies, Inc. · 2002
Descendant · cites it directly · 0 of its ownK023934 Rapid Thermal Exchange SystemAvacore Technologies, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all

K023934Rapid Thermal Exchange SystemAvacore Technologies, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970376	Ptca Guidewire	Lake Region Mfg., Inc.	1997	—
0 (this device)	K014210	Palmo Thermoregulation Interface Accessory	Avacore Technologies, Inc.	2002	—
+1	K023934	Rapid Thermal Exchange System	Avacore Technologies, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K014210, 1997–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K970376	Ptca Guidewire Summary page 1 …evices Cincinnati Subzero Blanketrol I1 Hyper-Hyopthermia System Preamendment Aquarius Thermo-STAT System K970376 Device Description The Palmo consists of three main parts: 1) a vacuum chamber that contains the 2) thermal exchange surface and…	Lake Region Mfg., Inc.	1997	—
*	—	Cincinnati Subzero Blanketrol II Hyper-Hypothermia System Named without a submission number			—

Also cleared against K970376: 6 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K023934	Rapid Thermal Exchange System	Avacore Technologies, Inc.	2003	0

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?

Its one ancestor has no recall.
Of its descendants, K023934 (Avacore Technologies, Inc., 2003) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K970376.

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

2007high 8 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWJ

131in 2025

2007high 180 (2011) · low 30 (2020)2026

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

Recalls per year · DWJ

3in 2024

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	106	0	52
2008	3	73	0	40
2009	3	106	6	71
2010	8	134	2	104
2011	4	180	7	136
2012	5	69	1	106
2013	5	77	2	73
2014	4	131	0	116
2015	0	—	1	245
2016	2	—	0	1,400
2017	5	153	3	1,473
2018	3	95	5	1,517
2019	2	—	3	2,294
2020	5	30	2	2,546
2021	2	—	1	2,689
2022	2	—	5	3,226
2023	6	42	0	3,455
2024	2	—	3	3,329
2025	3	131	0	2,384
2026	5	99	3	—

What is it indicated for?

The Palmo Thermoregulation Interface Accessory is designed to noninvasively lower or raise a patient’s temperature andor maintain a desired patient temperature. This is accomplished with local application of negative pressure and heatingcooling to a distal appendage.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K014210 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014210: Palmo Thermoregulation Interface Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014210

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026