510(k) · Cleared
ClearedOxitemp, 3301T SA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bci Intl., Inc. · DQA Oximeter
Cleared on May 15, 1996 after a 134-day review. The FDA summary names its predicate without a number.
- Decided
- May 15, 1996
- Review
- 134 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DQA? 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 DQA device
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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 |
|---|---|---|---|
| * | — | BCI 3301T OxiTemp Named without a submission number | |
| * | — | Exergen Ototemp Named without a submission number |
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.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The 3301 T OxiTemp provides fast, reliable SpO2, pulse rate and temperature measurements. It can be used in the hoapital or clinical enviromment, and during emergency sir or land transport. The oximeter will operate accurately over an ambient temperature range of 32 to 110° F (0 to 43° C). The IR ear thermometer uses & patented ambient temperature compensation technique that allows it to provide accurate patiest tamperatures over the ambient temperature…
Read the full statement (213 words)
The 3301 T OxiTemp provides fast, reliable SpO2, pulse rate and temperature measurements. It can be used in the hoapital or clinical enviromment, and during emergency sir or land transport. The oximeter will operate accurately over an ambient temperature range of 32 to 110° F (0 to 43° C). The IR ear thermometer uses & patented ambient temperature compensation technique that allows it to provide accurate patiest tamperatures over the ambient temperature rangs 60 to 110° F (16 40 43° C). Below 16°C (60°F) a low ambient message is displayed. The 3301T SA OxiTemp extonds the ambient temperature range the device can operats in up to 130°F (54°C) and down to 32°F (0°C).
‘The oximeter works with all BCT oximetry providing SpO2 and pulse rate on all patients from neonate to aduk (see the section THE PROBE under USING THE OXIMETER in the operations manual). For the 3301T the IR ear thermometer must seal the car canal opening and look into the ear canal t3 provide an accurate temperature measurement. Therefore, it is restricted to patients over two years of age. The 3301T SA provides tympanic temperature measurements. The probe must be able to fit into the ear canal for proper operation. Therefore, it is restricted to patients over three 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/K960058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960058: Oxitemp, 3301T SA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960058
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026