510(k) · Cleared
ClearedDisposable Blood Pressure Cuff Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pinhu Sama Medical Packing Co., Ltd. · DXQ Blood Pressure Cuff
Cleared on Apr 2, 2015 as substantially equivalent to K141998 (Pinghu Sama Medical Packing Co., Ltd., 2014) after a 59-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Apr 2, 2015
- Review
- 59 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952825 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK952825 Cuff GuardBowen Medical Services, Inc. · 1995
- 2 generations backK031195 Cuf-Cover (TM)Ethox Corp. · 2003
- 1 generation backK141998 Sama Disposable Blood Pressure Cuff BarriersPinghu Sama Medical Packing Co., Ltd. · 2014
- This deviceK150227 Disposable Blood Pressure Cuff GuardPinhu Sama Medical Packing Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952825 | Cuff Guard | Bowen Medical Services, Inc. | 1995 | — |
| −2 | K031195 | Cuf-Cover (TM) | Ethox Corp. | 2003 | — |
| −1 | K141998 | Sama Disposable Blood Pressure Cuff Barriers | Pinghu Sama Medical Packing Co., Ltd. | 2014 | — |
| 0 (this device) | K150227 | Disposable Blood Pressure Cuff Guard | Pinhu Sama Medical Packing Co., Ltd. | 2015 | — |
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 |
|---|---|---|---|
| * | K141998 | Sama Disposable Blood Pressure Cuff BarriersSummary page 6…o ends of outer guard, both of them are not contact with the patient skin. 5. Identification of Predicate Device(s) Predicate Device 510(k) Number: K141998 Product Name: SAMA Disposable Blood Pressure Cuff Barriers Model Name: Pinghu Sama Medical Packing Co., Ltd. 6. Non… | 2014 |
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 20 years and passes through 4 companies; a new generation was cleared every 8.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
This device has the potential to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150227: Disposable Blood Pressure Cuff Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150227
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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