510(k) · Cleared
ClearedUnimed Disposable Blood Pressure Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimed Medical Supplies, Inc. · DXQ Blood Pressure Cuff
Cleared on May 4, 2012 as substantially equivalent to K974080 (Johnson & Johnson Medical, Inc., 1998) after an 88-day review. Its family tree reaches back 2 generations to 1979. 23 later devices descend from it.
- Decided
- May 4, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K790810 (1979). 6 ancestors in all. 23 later devices descend from it, 7 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 deviceK120364 Unimed Disposable Blood Pressure CuffUnimed Medical Supplies, Inc. · 2012
- Descendant · cites it directly · 9 of its ownK151290 Disposable Blood Pressure Cuff, Reusable Blood Pressure CuffXuzhou Maicuff Technology Co., Ltd. · 2015
- Descendant · cites it directly · 7 of its ownK182433 Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffShenzhen Caremed Medical Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 4 of its ownK152468 Reusable Blood Pressure CuffShenzhen Vistar Medical Supplies Co., Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK171889 Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK251045 Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal…Unimed Medical Supplies, Inc. · 2025
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K151290Disposable Blood Pressure Cuff, Reusable Blood Pressure CuffXuzhou Maicuff Technology Co., Ltd. · 2015 · cites it directly9descendants
- K182433Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffShenzhen Caremed Medical Technology Co., Ltd. · 2018 · cites it directly7descendants
- K152468Reusable Blood Pressure CuffShenzhen Vistar Medical Supplies Co., Ltd. · 2015 · 2 generations on4descendants
- K171889Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2017 · 3 generations on2descendants
- K251045Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff…Unimed Medical Supplies, Inc. · 2025 · cites it directly1descendant
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) | K120364 | Unimed Disposable Blood Pressure Cuff | Unimed Medical Supplies, Inc. | 2012 | — |
| +1 | K151290 | Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff | Xuzhou Maicuff Technology Co., Ltd. | 2015 | — |
| +1 | K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Shenzhen Caremed Medical Technology Co., Ltd. | 2018 | — |
| +2 | K152468 | Reusable Blood Pressure Cuff | Shenzhen Vistar Medical Supplies Co., Ltd. | 2015 | — |
| +3 | K171889 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2017 | — |
| +1 | K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff… | Unimed Medical Supplies, Inc. | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K974080 | Critikon Soft Blood Pressure CuffSummary page 1…d Pressure Cuff Common Name: Non-invasive Blood pressure cuff Product Code/Classification: DXQ/21 CFR87O. 1120 Review Panel: Cardiovascular Predicate Device Soft-Cuff (K974080) JOHNSON & JOHNSON MEDICAL, INC. (GE Healthcare) Intended Use The Unined disposable blood pressure cuff is an accessory used in… | 1998 |
What descends from it? (23)
See all 237 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151290 | Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff | 2015 | 9 |
| K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | 2018 | 7 |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff… | 2025 | 1 |
| K232772 | Blood Pressure Cuff… | 2023 | 1 |
| K203652 | Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff… | 2021 | 0 |
| K160530 | Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff | 2016 | 0 |
| K153251 | Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff | 2016 | 0 |
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 6 ancestors have a recall of any class.
- Of its descendants, K151290 (Xuzhou Maicuff Technology Co., Ltd., 2015) has gone furthest, with 9 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?
The Unined disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, 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/K120364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120364: Unimed Disposable Blood Pressure Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120364
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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