510(k) · Cleared
ClearedVital Statistics System (O-Cath Accessory)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quinton, Inc. · DQA Oximeter
Cleared on May 21, 1997 as substantially equivalent to K913695 (Nellcor, Inc., 1991) and 1 other predicate after a 160-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- May 21, 1997
- Review
- 160 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913695 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK913695 Nellcor (R) N-180 Pulse OximeterNellcor, Inc. · 1991
- This deviceK964978 Vital Statistics System (O-Cath Accessory)Quinton, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913695 | Nellcor (R) N-180 Pulse Oximeter | Nellcor, Inc. | 1991 | — |
| 0 (this device) | K964978 | Vital Statistics System (O-Cath Accessory) | Quinton, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (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 |
|---|---|---|---|
| * | K913695 | Nellcor (R) N-180 Pulse OximeterSummary page 1…Nellcor Puritan Bennett N-180 Puise Oximeter and the Colin Medical Instrument - BP-508 Patient Monitor (PILOT model No. 9200) . The 510(k) numbers for these devices are K913695 and K922668, respectively. 000022 . - C. Device Description The Vital Statistics System (VSS) is an accessory t… | 1991 |
| * | K922668 | Pilot Model 9200 Blood Pressure Measurement System Cleared while this submission was under review Summary page 1…itan Bennett N-180 Puise Oximeter and the Colin Medical Instrument - BP-508 Patient Monitor (PILOT model No. 9200) . The 510(k) numbers for these devices are K913695 and K922668, respectively. 000022 . - C. Device Description The Vital Statistics System (VSS) is an accessory to the Quinto… | 1997 |
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 2 ancestors has a recall.
- 5 other devices also cite its predicate K913695.
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 intended use of the Quinton Vital Statistics System (Q-Cath Accessory) is the acquisition, calculation, and transmission of physiological parameters as diastolic and systolic blood pressure, blood oxygen saturation levels, and heart rate to the Quinton Q-Cath during cardiac cath procedures.
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/K964978 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964978: Vital Statistics System (O-Cath Accessory).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964978
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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