510(k) · Cleared
ClearedDevon Accubp Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Devon Medical, Inc. · DXQ Blood Pressure Cuff
Cleared on Mar 23, 2009 as substantially equivalent to K071244 (Medline Industries, Inc., 2008) after a 10-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Mar 23, 2009
- Review
- 10 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071244 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK071244 Medline Single Patient Use Blood Pressure CuffMedline Industries, Inc. · 2008
- This deviceK090664 Devon Accubp CuffDevon Medical, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071244 | Medline Single Patient Use Blood Pressure Cuff | Medline Industries, Inc. | 2008 | — |
| 0 (this device) | K090664 | Devon Accubp Cuff | Devon Medical, Inc. | 2009 | — |
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 DXQ? 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 DXQ device
- #1 K254287 Medline Reusable Blood Pressure Cuffscore 13.3 · 7 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 |
|---|---|---|---|
| * | K071244 | Medline Single Patient Use Blood Pressure CuffSummary page 1…Predicate Devices The AccuBP Cuff is substantially equivalent to the following: Medline Single Patient Use Blood Pressure Cuff Medline Industries, Inc. K07 1244 The AccuBP Cuffhas the same intended use and general construction as the predicate devices and is available in the same sizes of… | 2008 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K071244.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DXQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXQ
174in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXQ
20in 2025
MAUDE reports naming product code DXQ, 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 | 2 | — | 0 | 3 |
| 2008 | 7 | 118 | 0 | 4 |
| 2009 | 5 | 57 | 0 | 2 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 5 | 121 | 1 | 5 |
| 2012 | 4 | 102 | 0 | 7 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 4 | 105 | 0 | 9 |
| 2015 | 10 | 59 | 0 | 23 |
| 2016 | 4 | 217 | 0 | 50 |
| 2017 | 2 | — | 0 | 67 |
| 2018 | 5 | 225 | 0 | 44 |
| 2019 | 3 | 44 | 0 | 41 |
| 2020 | 3 | 207 | 0 | 5 |
| 2021 | 4 | 105 | 0 | 12 |
| 2022 | 4 | 105 | 0 | 3 |
| 2023 | 5 | 79 | 0 | 20 |
| 2024 | 2 | — | 0 | 15 |
| 2025 | 3 | 174 | 1 | 20 |
| 2026 | 4 | 102 | 0 | — |
What is it indicated for?
The Devon AccuBP Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, through adult sizes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090664: Devon Accubp Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090664
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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