510(k) · Cleared
ClearedKeller Pulse Oximeter, Model 850+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keller Medical Specialties Products, Inc. · DQA Oximeter
Cleared on Sep 11, 1998 as substantially equivalent to K895987 (Keller Medical Specialties Products, Inc., 1990) after a 71-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Sep 11, 1998
- Review
- 71 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895987 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK895987 Keller Pulse Oximeter - KMS 850Keller Medical Specialties Products, Inc. · 1990
- This deviceK982331 Keller Pulse Oximeter, Model 850+Keller Medical Specialties Products, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK990648 Keller Vital Signs Monitor, KMS 890+Keller Medical Specialties Products, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K990648Keller Vital Signs Monitor, KMS 890+Keller Medical Specialties Products, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895987 | Keller Pulse Oximeter - KMS 850 | Keller Medical Specialties Products, Inc. | 1990 | — |
| 0 (this device) | K982331 | Keller Pulse Oximeter, Model 850+ | Keller Medical Specialties Products, Inc. | 1998 | — |
| +1 | K990648 | Keller Vital Signs Monitor, KMS 890+ | Keller Medical Specialties Products, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (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 |
|---|---|---|---|
| * | K895987 | Keller Pulse Oximeter - KMS 850Summary page 1…ical Specialties 42609 Crawford Road Antioch Road, Illinois 60002 Registration: 1421498 Device: Model 850+ Pulse Oximeter Substantially Equivalent: Keller Model 850 (k895987) and numerous competitor’s models Contact; Jean Keller President DESCRIPTION: The Keller Model 850+ Pulse Oximeter is a portabl… | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990648 | Keller Vital Signs Monitor, KMS 890+ | 1999 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K990648 (Keller Medical Specialties Products, Inc., 1999) has gone furthest, with 0 descendants of its own.
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 Keller Medical Specialties Pulse Oximeter Model 850+ measures and monitors arterial oxygen saturation (Sa02) and pulse rate using standard dual wavelength pulse oximetry techniques.
This unit is portable with battery operation. The oximeter allows complete control of patient alarm limit settings.
This unit is not intended for use on neonates.
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/K982331 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982331: Keller Pulse Oximeter, Model 850+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982331
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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