510(k) · Cleared
ClearedPaci-Temp, Pacifier with Digital Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Product Limited Co. · FLL Continuous Measurement Thermometer
Cleared on Dec 18, 1995 after a 230-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 18, 1995
- Review
- 230 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK952073 Paci-Temp, Pacifier with Digital ThermometerIntelligent Product Limited Co. · 1995
- Descendant · cites it directly · 3 of its ownK972259 Pro Check Digital Pacifier ThermometerMicro Weiss Electronics · 1997
- Descendant · 2 generations on · 1 of its ownK051100 Modification to: Microlife Digital Pacifier Thermometer, Model MT1751QMicrolife Intellectual Property GmbH · 2005
- Descendant · 3 generations on · 0 of its ownK120671 Digital Pacifier Thermometer (Model NO.: TM-03)Cotronic Technology Limited · 2013
- Descendant · cites it directly · 0 of its ownK022542 Philips Baby Thermometer Set (SBC SC530)Philips Consumer Electronics · 2002
- Descendant · cites it directly · 0 of its ownK983619 Barchens Company Digital Pacifier ThermometerBarchens Co. · 1998
Most influential descendants
Showing 5 of 5 · See all- K972259Pro Check Digital Pacifier ThermometerMicro Weiss Electronics · 1997 · cites it directly3descendants
- K051100Modification to: Microlife Digital Pacifier Thermometer, Model MT1751QMicrolife Intellectual Property GmbH · 2005 · 2 generations on1descendant
- K120671Digital Pacifier Thermometer (Model NO.: TM-03)Cotronic Technology Limited · 2013 · 3 generations on0descendants
- K022542Philips Baby Thermometer Set (SBC SC530)Philips Consumer Electronics · 2002 · cites it directly0descendants
- K983619Barchens Company Digital Pacifier ThermometerBarchens Co. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952073 | Paci-Temp, Pacifier with Digital Thermometer | Intelligent Product Limited Co. | 1995 | — |
| +1 | K972259 | Pro Check Digital Pacifier Thermometer | Micro Weiss Electronics | 1997 | — |
| +2 | K051100 | Modification to: Microlife Digital Pacifier Thermometer, Model MT1751Q | Microlife Intellectual Property GmbH | 2005 | — |
| +3 | K120671 | Digital Pacifier Thermometer (Model NO.: TM-03) | Cotronic Technology Limited | 2013 | — |
| +1 | K022542 | Philips Baby Thermometer Set (SBC SC530) | Philips Consumer Electronics | 2002 | — |
| +1 | K983619 | Barchens Company Digital Pacifier Thermometer | Barchens Co. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
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.
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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K972259 (Micro Weiss Electronics, 1997) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K952073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952073: Paci-Temp, Pacifier with Digital Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952073
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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