510(k) · Cleared
ClearedSama Disposable Blood Pressure Cuff Barriers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pinghu Sama Medical Packing Co., Ltd. · DXQ Blood Pressure Cuff
Cleared on Sep 19, 2014 as substantially equivalent to K031195 (Ethox Corp., 2003) after a 58-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Sep 19, 2014
- Review
- 58 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952825 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK952825 Cuff GuardBowen Medical Services, Inc. · 1995
- 1 generation backK031195 Cuf-Cover (TM)Ethox Corp. · 2003
- This deviceK141998 Sama Disposable Blood Pressure Cuff BarriersPinghu Sama Medical Packing Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK150227 Disposable Blood Pressure Cuff GuardPinhu Sama Medical Packing Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150227Disposable Blood Pressure Cuff GuardPinhu Sama Medical Packing Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952825 | Cuff Guard | Bowen Medical Services, Inc. | 1995 | — |
| −1 | K031195 | Cuf-Cover (TM) | Ethox Corp. | 2003 | — |
| 0 (this device) | K141998 | Sama Disposable Blood Pressure Cuff Barriers | Pinghu Sama Medical Packing Co., Ltd. | 2014 | — |
| +1 | K150227 | Disposable Blood Pressure Cuff Guard | Pinhu Sama Medical Packing Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K031195 | Cuf-Cover (TM)Summary page 4…II Regulation Number: 21 CFR 870.1120 Panel: General Cardiovascular Product Code: DXQ 5.5 Predicate Device Information: (1) K031195, “Cuf-Cover”, manufactured by “Ethox Corp”, Located in Buffalo, NY, USA 5.6 Device description: This device is a cov… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150227 | Disposable Blood Pressure Cuff Guard | 2015 | 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 19 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K150227 (Pinhu Sama Medical Packing Co., Ltd., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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/K141998 · printed Nov 3, 2026
Cite this page
510(k) Report. “K141998: Sama Disposable Blood Pressure Cuff Barriers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K141998
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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