510(k) · Cleared
ClearedBarchens Company Digital Pacifier Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barchens Co. · FLL Continuous Measurement Thermometer
Cleared on Nov 2, 1998 as substantially equivalent to K972259 (Micro Weiss Electronics, 1997) and 2 other predicates after an 18-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Nov 2, 1998
- Review
- 18 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K952073 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952073 | Paci-Temp, Pacifier with Digital Thermometer | Intelligent Product Limited Co. | 1995 | — |
| −1 | K972259 | Pro Check Digital Pacifier Thermometer | Micro Weiss Electronics | 1997 | — |
| 0 (this device) | K983619 | Barchens Company Digital Pacifier Thermometer | Barchens Co. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (3)
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 |
|---|---|---|---|
| * | K972259 | Pro Check Digital Pacifier ThermometerSummary page 1…ary Prepared: October 13, 1998 Name of the Device: Barchens Digital Pacifier Thermometer Predicate Device Information: 1. The Pru-Check™ Pacifler Digital 1hermometer K#972259. 2. The Pasi-Temp Pacifier Digital Thermometer, K#952073. Intelligent Product Ltd. Co., Orem, Utah (presently owned by Acute Ide… | 1997 |
| * | K952073 | Paci-Temp, Pacifier with Digital ThermometerSummary page 1…s Digital Pacifier Thermometer Predicate Device Information: 1. The Pru-Check™ Pacifler Digital 1hermometer K#972259. 2. The Pasi-Temp Pacifier Digital Thermometer, K#952073. Intelligent Product Ltd. Co., Orem, Utah (presently owned by Acute Ideas Co., Ltd)) 3. The Basis® Baby-Temp Pacifier Digital Th… | 1995 |
| * | K962991 | Basis Baby-Temp Pacifier Digital TherometerSummary page 1…gital Thermometer, K#952073. Intelligent Product Ltd. Co., Orem, Utah (presently owned by Acute Ideas Co., Ltd)) 3. The Basis® Baby-Temp Pacifier Digital Thermometer, K#962991, Polymedica Indistries. Ins. Golden Colorada Device Description: The Barchens Digital Pacifier Thermometer, is a battery-powere… | 1996 |
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 3 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K972259.
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 Barchens Digital Pacifier Thermometer is a non-sterile, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five years of age.
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/K983619 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983619: Barchens Company Digital Pacifier Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983619
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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