510(k) · Cleared
ClearedRadial-Cuf Non-Invasive Blood Pressure Cuff
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 Apr 9, 2013 as substantially equivalent to K120125 (Ge Medical Systems Information Technologies, Inc., 2012) after a 104-day review. Its family tree reaches back 3 generations to 1979.
- Decided
- Apr 9, 2013
- Review
- 104 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- 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 deviceK123996 Radial-Cuf Non-Invasive Blood Pressure CuffGe Medical Systems Information Technologies, Inc. · 2013
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) | K123996 | Radial-Cuf Non-Invasive Blood Pressure Cuff | Ge Medical Systems Information Technologies, Inc. | 2013 | — |
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 1…ure Cuff Commnon/Usual Name: Blood Pressure Cuff Classification Names: Blood Pressure Cuff Product Code: DXQ Predicate Device(s): K120125 Non-Invasive Blood Pressure Cuffs Device Description: The RADIAL-CUF is a Non-Invasive Blood Pressure cuff that… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 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. 2013, 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?
GE CRITIKON blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems. The RADIAL-CUF is intended for use with automated oscillometric NIBP devices to measure radial arterial pressure on the forearm. The RADIAL-CUF is available in adult size only. The device is non-sterile and is semi-disposable (may be single-patient use or optional limited reuse). The cuff is intended for use in patients whose…
Read the full statement (134 words)
GE CRITIKON blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems. The RADIAL-CUF is intended for use with automated oscillometric NIBP devices to measure radial arterial pressure on the forearm. The RADIAL-CUF is available in adult size only. The device is non-sterile and is semi-disposable (may be single-patient use or optional limited reuse). The cuff is intended for use in patients whose upper arm circumference is greater than 40cm or in patients where currently marketed GE CRITIKON upper arm cuffs cannot be used, due to excess width of the cuff or conical shape of the upper arm. The forearm cuff is intended to be placed on the patient's forearm with circumference ranging from 26cm -36cm. The devices are not designed, sold or intended for use except as indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123996 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123996: Radial-Cuf Non-Invasive Blood Pressure Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123996
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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