510(k) · Cleared
Recalled · Class II · 2024One-Cuf
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies, Inc. · DXQ Blood Pressure Cuff
Cleared on Mar 14, 2023 as substantially equivalent to K120125 (Ge Medical Systems Information Technologies, Inc., 2012) after a 55-day review. Its family tree reaches back 3 generations to 1979. It has been recalled once.
- Decided
- Mar 14, 2023
- Review
- 55 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K790810 (1979). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
- 2 generations backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- 1 generation backK120125 Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-CufGe Medical Systems Information Technologies, Inc. · 2012
- This deviceK230145 One-CufGe Medical Systems Information Technologies, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K790810 | Disposa-Cuf | Crest Medical Equipment | 1979 | — |
| −2 | K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. | 1998 | 1 |
| −1 | K120125 | Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-Cuf | Ge Medical Systems Information Technologies, Inc. | 2012 | — |
| 0 (this device) | K230145 | One-Cuf | Ge Medical Systems Information Technologies, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 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 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 13.4 · 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 |
|---|---|---|---|
| * | K120125 | Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-CufSummary page 4…ressure Cuff Regulation 21 CFR 870.1120 Blood Pressure Cuff Classification II Product Code: DXQ Predicate Device: SOFT-CUF (K120125) Intended Use Indirect measurement of blood pressure Indications for Use: The blood pressure cuff is an accessory… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2024 | Class II | Z-2027-2024 | Under Investigation by firm | Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 44 years and passes through 3 companies; a new generation was cleared every 14.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K120125.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 blood pressure cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. It is non-sterile, single-patient use. It is available in pediatric and adult sizes. The cuff is not designed, sold or intended for use except as indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230145 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230145: One-Cuf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230145
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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