510(k) · Cleared
ClearedReusable Finger Sensor 3444
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bci Intl., Inc. · DQH Cardiograph, Apex (Vibrocardiograph)
Cleared on Mar 11, 1998 after an 85-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 11, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- DQH
- 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 DQH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 3044 Reusable Finger Sensor 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 DQH devicesDQH Cardiograph, Apex (Vibrocardiograph): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQH
FDA has decided no DQH device since 2007.
Median 510(k) review, days · DQH
Too few DQH 510(k)s in any year since 2007 to give a median.
Recalls per year · DQH
No recall names DQH since 2007.
Adverse event reports per year · DQH
No MAUDE report names DQH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 3444 Reusable Finger Sensor is used with BCI oximetry to noninvasively measure oxygen saturation (SpO₂), pulse rate and plethysmographic pulse waves. The 3444 sensor is recommended for patients weighing more than 15 kg and patients with limited activity.
The 3444 Reusable Finger Sensor is not recommended for prolonged use unless skin integrity is checked frequently and the measurement site is changed accordingly.
The Reusable Finger Sensor is for use with BCI International monitors and with monitors that contain BCI International oximetry or are licensed to use BCI International sensors.
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/K974697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974697: Reusable Finger Sensor 3444.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974697
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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