510(k) · Cleared
ClearedBasis Baby-Temp Pacifier Digital Therometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymedica Industries, Inc. · FLL Continuous Measurement Thermometer
Cleared on Sep 12, 1996 after a 42-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Sep 12, 1996
- Review
- 42 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK962991 Basis Baby-Temp Pacifier Digital TherometerPolymedica Industries, Inc. · 1996
- 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 ownK983619 Barchens Company Digital Pacifier ThermometerBarchens Co. · 1998
Most influential descendants
Showing 4 of 4 · 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
- 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) | K962991 | Basis Baby-Temp Pacifier Digital Therometer | Polymedica Industries, Inc. | 1996 | — |
| +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 | 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 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | — | Questech International, Inc. WeeCare™ Pacifier Thermometer Named without a submission number | |
| * | — | Intelligent Product Limited Company Paci-Temp Pacifier with Digital Thermometer Named without a submission number |
What descends from it? (4)
2 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 | — |
What is it indicated for?
The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.
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/K962991 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962991: Basis Baby-Temp Pacifier Digital Therometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962991
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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