510(k) · Cleared

Cleared

Sabratek Apm-2000 Ambulatory Patient Montor, Transcutaneous Temperature Monitor

K983355510(k) TraditionalCleared Mar 12, 1999170-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

Sabratek Corp. · FLL Continuous Measurement Thermometer

Cleared on Mar 12, 1999 as substantially equivalent to K833568 (Diatek, Inc., 1984) after a 170-day review. Its family tree reaches back 1 generation to 1984.

Decided: Mar 12, 1999
Review: 170 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

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

By dateBy generation

Root · 1 generation backK833568 Diatek 600 Thermometer SystemDiatek, Inc. · 1984
This deviceK983355 Sabratek Apm-2000 Ambulatory Patient Montor, Transcutaneous…Sabratek Corp. · 1999

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)	K983355	Sabratek Apm-2000 Ambulatory Patient Montor, Transcutaneous Temperature Monitor	Sabratek Corp.	1999	—

FIG. 1 — Lineage of K983355, 1984–1999Source: 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
*	K833568	Diatek 600 Thermometer System Summary page 1 …nscutaneous Temperature (TcT) Monitor 21 CFR Part 880.2910 Clinical electronic thermometer No Performance Standards are in effect for this device. Diatek Thermometer, K833568, and Deep Body Thermometers Limited, pre 1976 device. Deep Body Diatek Thermometers Digital Limited Thermometer Patient body Pat…	Diatek, Inc.	1984	—
*	—	Deep Body Thermometers Limited Named without a submission number			—

Also cleared against K833568: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K833568.

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?

Measures and displays patient temperature as calibrated to the equivalent oral temperature standard. The APM-2000 Ambulatory Patient Transcutaneous Temperature Monitor is an element of the Sabratek Corporation APM-2000 System.

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/K983355 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983355: Sabratek Apm-2000 Ambulatory Patient Montor, Transcutaneous Temperature Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983355

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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