510(k) · Cleared
Recalled · 2009Accutorr V Monitor, Model 0998-00-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp., Patient Monitoring Division · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 8, 2009 as substantially equivalent to K983575 (Datascope Corp., 1999) after a 24-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it. It has been recalled once.
- Decided
- May 8, 2009
- Review
- 24 days
- Class
- Class II
- Product code
- DXN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983575 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983575 Accutorr Plus Non Invasive Blood Pressure Monitor, Model #…Datascope Corp. · 1999
- This deviceK091068 Accutorr V Monitor, Model 0998-00-2000Datascope Corp., Patient Monitoring Division · 2009
- Descendant · cites it directly · 0 of its ownK110156 Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,Contec Medical System Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK091834 Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division · 2009 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983575 | Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XX | Datascope Corp. | 1999 | — |
| 0 (this device) | K091068 | Accutorr V Monitor, Model 0998-00-2000 | Datascope Corp., Patient Monitoring Division | 2009 | — |
| +1 | K110156 | Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer, | Contec Medical System Co., Ltd. | 2011 | — |
| +1 | K091834 | Passport V Monitor, Model 0998-00-6100 | Datascope Corp., Patient Monitoring Division | 2009 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K983575 | Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XXSummary page 1…Device Classification: Cardiovascular, Class II, 21 CFR 870.1130, Product Code DXN. Predicate Devices: Accutorr Plus Noninvasive Blood Pressure Monitor - K983575 Device description: The Accutorr V Monitor is a vital signs monitor intended for use in a he… | 1999 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 31, 2009 | Not classified | Z-1396-2010 | Process control | SmarTemp Disposable Probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The intended use of the Accutorr V is to monitor physiologic parameter data on adult,
pediatric and neonatal patients. The physiologic parameters measured includes:
noninvasive blood pressure (NIBP), pulse oximetry (SpO 2), heart rate and temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091068 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091068: Accutorr V Monitor, Model 0998-00-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091068
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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