510(k) · Cleared

Cleared

Entracare Thermomter Model 1000

K964851510(k) TraditionalCleared Feb 3, 199762-day reviewClass II21 CFR 880.2910

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

Entracare Corp. · FLL Continuous Measurement Thermometer

Cleared on Feb 3, 1997 as substantially equivalent to K860436 (Y, 1986) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1984.

Decided: Feb 3, 1997
Review: 62 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K833568 (1984). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK833568 Diatek 600 Thermometer SystemDiatek, Inc. · 1984
This deviceK964851 Entracare Thermomter Model 1000Entracare Corp. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K833568	Diatek 600 Thermometer System	Diatek, Inc.	1984	—
0 (this device)	K964851	Entracare Thermomter Model 1000	Entracare Corp.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0

FIG. 1 — Lineage of K964851, 1984–1997Source: 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 FLL? 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 FLL device

#1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 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
*	K860436	Ivac Model 2080 Electronic Thermometer Summary page 1 …latory Affairs EntraCare 1000 Thermometer Thermometer Thermometer, Electronic, Clinical Class II 1. Ivac Corp., Temp-Plus Vital Signs Measurement System, Model 2080 (K860436). 2. Diatek, Thermometer System, Model 600 (K833568). EntraCare Corp. 510(k) SUMMARY Page 2 of 3 DESCRIPTION O…	Y	1986	—
*	K833568	Diatek 600 Thermometer System Summary page 1 …r Thermometer, Electronic, Clinical Class II 1. Ivac Corp., Temp-Plus Vital Signs Measurement System, Model 2080 (K860436). 2. Diatek, Thermometer System, Model 600 (K833568). EntraCare Corp. 510(k) SUMMARY Page 2 of 3 DESCRIPTION OF DEVICE: The EntraCare Thermometer, Model 1000, is…	Diatek, Inc.	1984	—

Also cleared against K860436: 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?

None of the 2 ancestors has a recall.
2 other devices also cite its predicate K860436.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLL

6in 2025

2007high 43 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLL

131in 2025

2007high 295 (2023) · low 59 (2008)2026

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

Recalls per year · FLL

1in 2025

2007high 5 (2019) · low 0 (2007)2026

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

Adverse event reports per year · FLL

73in 2025

2007high 142 (2022) · low 4 (2007)2025

MAUDE reports naming product code FLL, 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	15	81	0	4
2008	14	59	0	13
2009	13	84	0	9
2010	24	88	0	9
2011	20	113	1	18
2012	17	126	0	26
2013	14	149	0	16
2014	7	199	0	54
2015	3	270	1	53
2016	22	157	0	58
2017	16	174	2	118
2018	35	209	1	51
2019	22	198	5	52
2020	21	194	0	53
2021	43	218	0	115
2022	24	218	0	142
2023	17	295	0	101
2024	13	223	0	118
2025	6	131	1	73
2026	2	—	1	—

What is it indicated for?

The EntraCare Thermometer, Model 1000, is intended to be used under a physicians orders when an accurate temperature measurement is required. The device is intended to be used orally or rectally in the human body temperature range of 92°F to 108°F. It may be used with infants, children, or adults in all settings under the order of a physcian. The heart rate timer is also provided to aid in establishing a patients approximate heart rate.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964851 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964851: Entracare Thermomter Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964851

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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