FDA product code · General Hospital
FLLContinuous Measurement Thermometer
Product code FLL covers Continuous Measurement Thermometer, a Class II device regulated under 21 CFR 880.2910. FDA has cleared 798 devices in this code, 2 of them in the last 12 months. Median review time across the 798 most recent decisions is 108 days. openFDA lists 18 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 880.2910
- Review panel
- General Hospital
- Clearances
- 798
What is happening in FLL right now?
FLL (Continuous Measurement Thermometer) has two findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0233-2026). The code is crowded, scoring 68 of 100 — 415 companies hold a clearance here and 2 arrived in the last 12 months (FLL:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0233-2026 |
| Crowding | Context | FLL:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code FLL cover?
FLL is FDA's product code for Continuous Measurement Thermometer, a Class II device regulated under 21 CFR 880.2910.
A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
Source: openFDA device/classification · record FLL · retrieved
How many devices has FDA cleared in FLL?
FDA has cleared 798 devices under product code FLL since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Unimed Medical Supplies, Inc. | |
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | Shenzhen Med-Link Electronics Tech Co., Ltd. | |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | Shenzhen AOJ Medical Technology Co., Ltd. | |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | Shenzhen Medke Technology Co., Ltd. | |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | |
| K243082 | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. | |
| K250401 | AION TempShield | Aion Biosystems, Inc. | |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | Shenzhen Finicare Co., Ltd. | |
| K240333 | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | |
| K240223 | FMT Disposable and Autoclavable Temperature Probes | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi |
How long does FDA review take for FLL?
The median FDA review time for FLL is 108 days, measured across the 798 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in FLL?
openFDA lists 18 recall records against product code FLL. A recall record covers one firm's corrective action and may span many device lots.
Z-0233-2026Open, ClassifiedBaxter Healthcare Corporation
Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
Z-2339-2024Open, ClassifiedBaxter Healthcare Corporation
The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
Z-2482-2021Open, ClassifiedWelch Allyn Inc
If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient
Z-0990-2020TerminatedCardinal Health 200, LLC
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3.
Z-0991-2020TerminatedCardinal Health 200, LLC
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3.
Showing the 5 most recently initiated of 18. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for FLL?
MAUDE holds 281 adverse-event reports naming product code FLL, 43 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in FLL unusual?
Every month with enough history behind it falls inside FLL's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 7 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 8 | 1–16 | Within expected (1–16) | |
| 3 | 1–14 | Within expected (1–14) | |
| 5 | 0–15 | Within expected (0–15) | |
| 9 | 0–14 | Within expected (0–14) | |
| 8 | 0–13 | Within expected (0–13) | |
| 6 | 1–14 | Within expected (1–14) | |
| 8 | 0–22 | Within expected (0–22) | |
| 6 | 0–15 | Within expected (0–15) | |
| 3 | 0–15 | Within expected (0–15) | |
| 8 | 0–14 | Within expected (0–14) | |
| 3 | 1–11 | Within expected (1–11) | |
| 6 | 0–11 | Within expected (0–11) | |
| 9 | 1–13 | Within expected (1–13) | |
| 5 | 1–11 | Within expected (1–11) | |
| 4 | 1–11 | Within expected (1–11) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in FLL.
What are the predicate devices in FLL?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in FLL?
Across the 798 most recent decisions, these applicants filed most often in FLL.
| Applicant | Recent clearances |
|---|---|
| Microlife Intellectual Property GmbH | 20 |
| R & D Batteries, Inc. | 19 |
| Taidoc Technology Corporation | 16 |
| Radiant Innovation, Inc. | 15 |
| K-Jump Health Co., Ltd. | 14 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch FLL
Get an email the morning anything changes in FLL — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.