510(k) · Cleared
ClearedMedline Reusable Blood Pressure Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, LP · DXQ Blood Pressure Cuff
Cleared on Jun 22, 2026 as substantially equivalent to K233276 (Suzhou Minhua Medical Apparatus Supplies Co., Ltd., 2023) after a 173-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Jun 22, 2026
- Review
- 173 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010686 (2001). 18 ancestors in all, the oldest K790810 (1979). No later device cites it as a predicate yet.
- Root · 7 generations backK010686 KTJ-20C Blood Pressure Cuff, Model KTJ-20CGolden Horse Medical Equipment (Wuxi) Co., Ltd. · 2001
- 6 generations backK051539 Tricot Blood Pressure CuffYa Horng Electronic Co., Ltd. · 2005
- 5 generations backK062238 Tytan Blood Pressure CuffTytan Medical Corp. · 2006
- 4 generations backK102825 Blood Pressure CuffAPK Technology Co., Ltd. · 2011
- 3 generations backK133117 Andon Blood Pressure CuffAndon Health Co, Ltd. · 2014
- 2 generations backK171889 Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2017
- 1 generation backK233276 Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2023
- This deviceK254287 Medline Reusable Blood Pressure CuffMedline Industries, LP · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010686 | KTJ-20C Blood Pressure Cuff, Model KTJ-20C | Golden Horse Medical Equipment (Wuxi) Co., Ltd. | 2001 | — |
| −6 | K051539 | Tricot Blood Pressure Cuff | Ya Horng Electronic Co., Ltd. | 2005 | — |
| −5 | K062238 | Tytan Blood Pressure Cuff | Tytan Medical Corp. | 2006 | — |
| −4 | K102825 | Blood Pressure Cuff | APK Technology Co., Ltd. | 2011 | — |
| −3 | K133117 | Andon Blood Pressure Cuff | Andon Health Co, Ltd. | 2014 | — |
| −2 | K171889 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2017 | — |
| −1 | K233276 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2023 | — |
| 0 (this device) | K254287 | Medline Reusable Blood Pressure Cuff | Medline Industries, LP | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 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 K251045 Disposable Neonatal NIBP Cuff (U1682S-C51N)…score 13.3 · 3 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 |
|---|---|---|---|
| * | K233276 | Reusable Blood Pressure CuffSummary page 5…Code: DXQ Classification Panel: Cardiovascular Regulatory Class: II Regulation Number: 21 CFR 870.1120 Predicate Device Minhua Reusable Blood Pressure Cuffs cleared in K233276 Device Description Medline Reusable Blood Pressure Cuff is an accessory of non-invasive sphygmomanometers for measurement of blo… | 2023 |
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 25 years and passes through 7 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 18 ancestors have a recall of any class.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Medline Reusable Blood Pressure Cuffs are intended to be used by medical professionals in conjunction with non-invasive blood pressure measurement systems for the determination of a person's blood pressure. The cuffs are non-sterile, multi-patient use and are tested for up to 10,000 inflation cycles and 100 cleaning/Disinfection cycles. Medline Blood Pressure cuff adapters and connectors are intended to be used by medical professionals in conjunction…
Read the full statement (113 words)
The Medline Reusable Blood Pressure Cuffs are intended to be used by medical professionals in conjunction with non-invasive blood pressure measurement systems for the determination of a person's blood pressure. The cuffs are non-sterile, multi-patient use and are tested for up to 10,000 inflation cycles and 100 cleaning/Disinfection cycles.
Medline Blood Pressure cuff adapters and connectors are intended to be used by medical professionals in conjunction with non-invasive blood pressure systems and blood pressure cuffs for determination of a person’s blood pressure. The Blood Pressure Cuff adapter is for single monitor use only. The Blood Pressure Cuff adapter has been validated for use for up to 10,000 cycles or up to 10,000 connections/disconnections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254287: Medline Reusable 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/K254287
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026