510(k) · Cleared
ClearedCuff Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bowen Medical Services, Inc. · DXQ Blood Pressure Cuff
Cleared on Sep 15, 1995 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Sep 15, 1995
- Review
- 87 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK952825 Cuff GuardBowen Medical Services, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK031195 Cuf-Cover (TM)Ethox Corp. · 2003
- Descendant · 2 generations on · 1 of its ownK141998 Sama Disposable Blood Pressure Cuff BarriersPinghu Sama Medical Packing Co., Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK150227 Disposable Blood Pressure Cuff GuardPinhu Sama Medical Packing Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK963987 Camouflage Cuff SaversN.A. Braggs Medical, Inc. · 1997
Most influential descendants
Showing 4 of 4 · See all- K031195Cuf-Cover (TM)Ethox Corp. · 2003 · cites it directly2descendants
- K141998Sama Disposable Blood Pressure Cuff BarriersPinghu Sama Medical Packing Co., Ltd. · 2014 · 2 generations on1descendant
- K150227Disposable Blood Pressure Cuff GuardPinhu Sama Medical Packing Co., Ltd. · 2015 · 3 generations on0descendants
- K963987Camouflage Cuff SaversN.A. Braggs Medical, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952825 | Cuff Guard | Bowen Medical Services, Inc. | 1995 | — |
| +1 | K031195 | Cuf-Cover (TM) | Ethox Corp. | 2003 | — |
| +2 | K141998 | Sama Disposable Blood Pressure Cuff Barriers | Pinghu Sama Medical Packing Co., Ltd. | 2014 | — |
| +3 | K150227 | Disposable Blood Pressure Cuff Guard | Pinhu Sama Medical Packing Co., Ltd. | 2015 | — |
| +1 | K963987 | Camouflage Cuff Savers | N.A. Braggs Medical, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
2 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?
- Of its descendants, K031195 (Ethox Corp., 2003) has gone furthest, with 2 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.
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 | — |
https://510kreport.com/device/K952825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952825: 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/K952825
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026