510(k) · Cleared
ClearedTemperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimed Medical Supplies, Inc. · FLL Continuous Measurement Thermometer
Cleared on Jun 5, 2026 as substantially equivalent to K121427 (Unimed Medical Supplies, Inc., 2012) after a 252-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jun 5, 2026
- Review
- 252 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962070 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK962070 Ysi 400 Series Atuoclavable Reusable Temperature ProbeYellow Springs Instrument Co., Inc. · 1996 · Recalled
- 2 generations backK050837 Reusable Temperature Probes (M1024254 Skin Temperature Probe…GE Healthcare · 2005
- 1 generation backK121427 Unimed Temperature ProbeUnimed Medical Supplies, Inc. · 2012
- This deviceK253162 Temperature probes (T2252-PG); Temperature probes (TCMA-AG)…Unimed Medical Supplies, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962070 | Ysi 400 Series Atuoclavable Reusable Temperature Probe | Yellow Springs Instrument Co., Inc. | 1996 | 2 |
| −2 | K050837 | Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable… | GE Healthcare | 2005 | — |
| −1 | K121427 | Unimed Temperature Probe | Unimed Medical Supplies, Inc. | 2012 | — |
| 0 (this device) | K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature… | Unimed Medical Supplies, Inc. | 2026 | — |
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 26.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K121427 | Unimed Temperature ProbeSummary page 5…Class: II 3. Predicate Device 510(K) No. Trade Name K121427 UNIMED TEMPERATURE PROBE 4. Device Description This 510(k) submission includes five temperature probe mo… | 2012 |
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 30 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 6 other devices also cite its predicate K121427.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 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?
Reusable Temperature Probes: Unimed Reusable Temperature Probes are intended to be used for monitoring temperature by applying them to the esophageal or rectal site, depending on model. The temperature probes are reusable and designed for use with compatible patient monitors. These probes should be applied to a patient only under direct supervision of a licensed physician or health care provider. Probes must be cleaned, disinfected, and inspected for…
Read the full statement (131 words)
Reusable Temperature Probes:
Unimed Reusable Temperature Probes are intended to be used for monitoring temperature by applying them to the esophageal or rectal site, depending on model. The temperature probes are reusable and designed for use with compatible patient monitors. These probes should be applied to a patient only under direct supervision of a licensed physician or health care provider. Probes must be cleaned, disinfected, and inspected for damage before use.
Disposable Temperature Probes:
Unimed Disposable Temperature Probes are intended to be used for monitoring temperature by applying them to the esophageal or rectal site, depending on model. The temperature probes are disposable and designed for use with compatible patient monitors. These probes should be applied to a patient only under direct supervision of a licensed physician or health care provider.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253162 · printed Nov 3, 2026
Cite this page
510(k) Report. “K253162: Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K253162
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026