510(k) · Cleared

Cleared

Suretemp

K964643510(k) TraditionalCleared Jan 9, 199758-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

Diatek Instruments, Inc. · FLL Continuous Measurement Thermometer

Cleared on Jan 9, 1997 after a 58-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 436 devices in its family, counting itself, has a Class I recall. 435 later devices descend from it.

Decided: Jan 9, 1997
Review: 58 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 0

435 later devices descend from it, 3 citing it directly. 1 of the 436 devices in this family, counting this one, has a Class I recall.

This deviceK964643 SuretempDiatek Instruments, Inc. · 1997
Descendant · cites it directly · 425 of its ownK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
Descendant · 2 generations on · 272 of its ownK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
Descendant · 3 generations on · 264 of its ownK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
Descendant · 4 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
Descendant · 5 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007

Showing 5 of 435 descendants. See all descendants

Descendants cleared per year

1998high 31 (2025) · low 0 (2000)2026

Class I recalls in this family

K123690 CAPNOSTREAM20P with Hifi C02 Monitoring10 generations on · 2014

Most influential descendants

Showing 5 of 435 · See all

K9827769303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998 · cites it directly425descendants
K033048Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…Cas Medical Systems, Inc. · 2004 · 2 generations on272descendants
K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc. · 2005 · 3 generations on264descendants
K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 4 generations on250descendants
K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 5 generations on197descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K964643	Suretemp	Diatek Instruments, Inc.	1997	—
+1	K982776	9303 Neonatal/Adult Vital Signs Monitor	Cas Medical Systems, Inc.	1998	—
+2	K033048	Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL…	Cas Medical Systems, Inc.	2004	1
+3	K050844	750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL…	Cas Medical Systems, Inc.	2005	—
+4	K060065	CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…	Oridion Capnography, Inc.	2006	3
+5	K072295	Capnostream 20 with A2 Adaptive Averaging Software	Oridion Capnography, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	1	0
2002	2	0
2003	2	0
2004	7	0
2005	6	0
2006	6	0
2007	7	0
2008	6	0
2009	14	0
2010	12	0
2011	17	0
2012	26	0
2013	30	0
2014	24	1
2015	19	0
2016	18	0
2017	23	0
2018	23	0
2019	25	0
2020	25	0
2021	14	0
2022	29	0
2023	23	0
2024	25	0
2025	31	0
2026	18	0

FIG. 1 — Lineage of K964643, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (435)

See all 435

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

Number	Device	Applicant	Decided	Descendants
K982776	9303 Neonatal/Adult Vital Signs Monitor	Cas Medical Systems, Inc.	1998	425
K983887	UP-Grade and UP-Grade Pro	Medisim, Ltd.	1999	6
K980411	NPB3900 Series Patient Monitors	Analogic Corp.	1998	1

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 10 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K982776 (Cas Medical Systems, Inc., 1998) has gone furthest, with 425 descendants of its own.

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	—

https://510kreport.com/device/K964643 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964643: Suretemp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964643

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026