510(k) · Cleared
ClearedSoft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-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 Oct 3, 2012 as substantially equivalent to K974080 (Johnson & Johnson Medical, Inc., 1998) and 1 other predicate after a 260-day review. Its family tree reaches back 2 generations to 1979. 3 later devices descend from it.
- Decided
- Oct 3, 2012
- Review
- 260 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K790810 (1979). 7 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
- 1 generation backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- This deviceK120125 Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-CufGe Medical Systems Information Technologies, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK260747 YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden Corporation · 2026
- Descendant · cites it directly · 0 of its ownK230145 One-CufGe Medical Systems Information Technologies, Inc. · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK123996 Radial-Cuf Non-Invasive Blood Pressure CuffGe Medical Systems Information Technologies, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See all- K260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden Corporation · 2026 · cites it directly0descendants
- K230145One-CufGe Medical Systems Information Technologies, Inc. · 2023 · cites it directly0descendants
- K123996Radial-Cuf Non-Invasive Blood Pressure CuffGe Medical Systems Information Technologies, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K790810 | Disposa-Cuf | Crest Medical Equipment | 1979 | — |
| −1 | K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. | 1998 | 1 |
| 0 (this device) | K120125 | Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-Cuf | Ge Medical Systems Information Technologies, Inc. | 2012 | — |
| +1 | K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | Nihon Kohden Corporation | 2026 | — |
| +1 | K230145 | One-Cuf | Ge Medical Systems Information Technologies, Inc. | 2023 | 1 |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 13.3 · 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? (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 |
|---|---|---|---|
| * | K974080 | Critikon Soft Blood Pressure CuffSummary page 1…Common/Usual Name: Blood Pressure Cuff Classification Names: Blood Pressure Cuff Product Code: DXQ Predicate Device(s): K974080 Soft Blood Pressure Cuff K022482 SENSA CUFF Device Description: Non-Invasive Blood Press… | 1998 |
| * | K022482 | Sensa-Cuff, Models Infant, Child, AdultSummary page 1…fication Names: Blood Pressure Cuff Product Code: DXQ Predicate Device(s): K974080 Soft Blood Pressure Cuff K022482 SENSA CUFF Device Description: Non-Invasive Blood Pressure cuffs incorporate an inflatable non-… | 2002 |
What descends from it? (3)
3 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)
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 33 years and passes through 3 companies; a new generation was cleared every 19.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K260747 (Nihon Kohden Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K974080.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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. SOFT-CUF and CLASSIC-CUF cuffs and inflation systems are non-sterile and limited reuse (may be single-patient use or optional limited reuse). They are available in neonatal, pediatric and adult sizes. DURA-CUE and SENSA-CUF cuffs and inflation systems are non-sterile and may be reused. They are available in pediatric and adult sizes. 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/K120125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120125: Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-Cuf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120125
Report an extraction error
Are you the manufacturer?
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