510(k) · Cleared

Cleared

Vitalsense XHR

K061870510(k) SpecialCleared Aug 31, 200659-day reviewClass II21 CFR 882.1845

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

Respironics, Inc. · GWK Conditioner, Signal, Physiological

Cleared on Aug 31, 2006 as substantially equivalent to K033534 (Mini-Mitter Co., Inc., 2004) and 1 other predicate after a 59-day review. Its family tree reaches back 3 generations to 1991.

Decided: Aug 31, 2006
Review: 59 days
Class: Class II
Product code: GWK
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K914085 (1991). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK914085 HMS-5000Vitalog Monitoring,Inc. · 1991
2 generations backK991045 Mini-Logger Series 2000Mini-Mitter Co., Inc. · 1999
1 generation backK033534 VitalsenseMini-Mitter Co., Inc. · 2004
This deviceK061870 Vitalsense XHRRespironics, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K914085	HMS-5000	Vitalog Monitoring,Inc.	1991	—
−2	K991045	Mini-Logger Series 2000	Mini-Mitter Co., Inc.	1999	—
−1	K033534	Vitalsense	Mini-Mitter Co., Inc.	2004	—
0 (this device)	K061870	Vitalsense XHR	Respironics, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K061870, 1991–2006Source: 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 GWK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K033534	Vitalsense Summary page 1 …oner Common/Usual Name Physiological Signal Recorder Proprietary Name Respironics VitalSense XHR Predicate Device(s) VitalSense (K033534) Actiheart (K052489) Reason for submission Modified design. Description of Device: The…	Mini-Mitter Co., Inc.	2004	—
*	K052489	Actiheart Summary page 1 …Signal Recorder Proprietary Name Respironics VitalSense XHR Predicate Device(s) VitalSense (K033534) Actiheart (K052489) Reason for submission Modified design. Description of Device: The subject device can be classified as physiological…	Respironics, Inc.	2005	—

Also cleared against K033534: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
None of the 4 ancestors has a recall.
2 other devices also cite its predicate K033534.

How does its category compare?

All GWK devices

GWK Conditioner, Signal, Physiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWK

FDA has decided no GWK device since 2007.

Median 510(k) review, days · GWK

Too few GWK 510(k)s in any year since 2007 to give a median.

Recalls per year · GWK

No recall names GWK since 2007.

Adverse event reports per year · GWK

1in 2013

2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code GWK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	1
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The VitalSense XHR can be used in any setting where physiological body core temperature, skin temperature, or heart rate are used to further the understanding of body function or where quantifiable analysis of temperature or heart rate data is desirable.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061870 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061870: Vitalsense XHR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061870

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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