510(k) · Cleared
ClearedNellcor Puritan Bennett Uniprobe Adapter Cable, UP12A, UP12B, UP12C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor Puritan Bennett, Inc. · DQA Oximeter
Cleared on Dec 7, 1998 as substantially equivalent to K850494 (Ohmeda Medical, 1985) and 4 other predicates after a 124-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Dec 7, 1998
- Review
- 124 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K850494 (1985). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK850494 Ohmeda Biox 3700 Pulse OximeterOhmeda Medical · 1985
- This deviceK982728 Nellcor Puritan Bennett Uniprobe Adapter Cable, UP12A, UP12B, UP12CNellcor Puritan Bennett, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850494 | Ohmeda Biox 3700 Pulse Oximeter | Ohmeda Medical | 1985 | — |
| 0 (this device) | K982728 | Nellcor Puritan Bennett Uniprobe Adapter Cable, UP12A, UP12B, UP12C | Nellcor Puritan Bennett, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1993 | 1 | 0 |
| 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 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
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K850494 | Ohmeda Biox 3700 Pulse OximeterSummary page 1…Ohmeda sensor. The 510(k) numbers for the specified monitors/Ohmeda sensor combination are listed below: Product | 510(k) Number % Date Cleared fl Ohmeda Biox 3700/3700e K850494 3/28/85 Pulse Oximeter Ohmeda Biox 3740 Pulse K872772 10/7/87 Oximeter Ohmeda Biox 3760 Puise K874104 12/3/87 Oximeter Ohmeda… | 1985 |
| * | K872772 | Ohmeda Biox 3740 Pulse OximeterSummary page 1…tors/Ohmeda sensor combination are listed below: Product | 510(k) Number % Date Cleared fl Ohmeda Biox 3700/3700e K850494 3/28/85 Pulse Oximeter Ohmeda Biox 3740 Pulse K872772 10/7/87 Oximeter Ohmeda Biox 3760 Puise K874104 12/3/87 Oximeter Ohmeda 3800 Pulse Oximeter ’K9621 27 10/10/96 Marquette Tram… | 1987 |
| * | K874104 | Ohmeda Biox 3760 Pulse OximeterSummary page 1…Product | 510(k) Number % Date Cleared fl Ohmeda Biox 3700/3700e K850494 3/28/85 Pulse Oximeter Ohmeda Biox 3740 Pulse K872772 10/7/87 Oximeter Ohmeda Biox 3760 Puise K874104 12/3/87 Oximeter Ohmeda 3800 Pulse Oximeter ’K9621 27 10/10/96 Marquette Tram Modules K921669 5/7/93 Nellcor Puritan Bennett I… | 1987 |
| * | K962127 | Ohmeda 3800 Pulse OximeterSummary page 1…700/3700e K850494 3/28/85 Pulse Oximeter Ohmeda Biox 3740 Pulse K872772 10/7/87 Oximeter Ohmeda Biox 3760 Puise K874104 12/3/87 Oximeter Ohmeda 3800 Pulse Oximeter ’K9621 27 10/10/96 Marquette Tram Modules K921669 5/7/93 Nellcor Puritan Bennett Inc, 510¢k) Premarket Notification UniProbe Adapter Cab… | 1996 |
| * | K921669 | Marquette SL Series Transport Remote AcquisitionSummary page 1…Ohmeda Biox 3740 Pulse K872772 10/7/87 Oximeter Ohmeda Biox 3760 Puise K874104 12/3/87 Oximeter Ohmeda 3800 Pulse Oximeter ’K9621 27 10/10/96 Marquette Tram Modules K921669 5/7/93 Nellcor Puritan Bennett Inc, 510¢k) Premarket Notification UniProbe Adapter Cable #K982728 Additiong] Information - Co… | 1993 |
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?
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K850494.
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 UniProbe Adapter Cable allows specified Nellcor brand reusable and patient-dedicated oxygen sensors to be used with specified Ohmeda and Ohmeda-compatible Marquette Tram pulse oximetry monitors, to provide noninvasive measurement of oxygen saturation and pulse rate, The intended patient population for the UniProbe Adapter Cable includes adult, pediatric and neonatal patients, Use with any particular patient requires selection of an appropriate…
Read the full statement (128 words)
The UniProbe Adapter Cable allows specified Nellcor brand reusable and patient-dedicated oxygen sensors to be used with specified Ohmeda and Ohmeda-compatible Marquette Tram pulse oximetry monitors, to provide noninvasive measurement of oxygen saturation and pulse rate,
The intended patient population for the UniProbe Adapter Cable includes adult, pediatric and neonatal patients, Use with any particular patient requires selection of an appropriate Nellcor brand oxygen sensor.
The UniProbe Adapter Cable may be used in any hospital or hospital-type environment where the specified compatible monitors may be used. The UniProbe is contraindicated for use during MRI scanning. The UniProbe Adapter Cable is NOT intended for use in the home care environment. The UniProbe Adapter Cable is a prescription device and is to be used by qualified health care professionals only,
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/K982728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982728: Nellcor Puritan Bennett Uniprobe Adapter Cable, UP12A, UP12B, UP12C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982728
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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