510(k) · Cleared
ClearedSurgi-Cuf Reusable, RS Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethox International · DXQ Blood Pressure Cuff
Cleared on Jul 25, 2006 as substantially equivalent to K022482 (Ge Medical Systems Information Technologies, 2002) and 1 other predicate after a 13-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jul 25, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K883977 (1989). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883977 | Surgi-Cuf Sterile/Non-Sterile Disposable | Ethox Corp. | 1989 | — |
| −1 | K040286 | Ethox Surgi-Cuf Adult Disposable Blood Pressure Cuffs | Ethox Corp. | 2004 | — |
| 0 (this device) | K061962 | Surgi-Cuf Reusable, RS Series | Ethox International | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 13.3 · 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? (3)
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 |
|---|---|---|---|
| * | K022482 | Sensa-Cuff, Models Infant, Child, AdultSummary page 2…2 === Predicate Devices: The SURGI-CUF® REUSABLE Blood Pressure Cuff is substantially equivalent to the following predicate devices: K022482; Sensa-Cuff; GE Medical Systems Information Technologies Preamendent; CRITIKON DURA-CUF®; Critikon Company, LLC.… | 2002 |
| * | K040286 | Ethox Surgi-Cuf Adult Disposable Blood Pressure CuffsSummary page 2…es: K022482; Sensa-Cuff; GE Medical Systems Information Technologies Preamendent; CRITIKON DURA-CUF®; Critikon Company, LLC. K040286, SURGI-CUF®; Ethox Corporation The SURGI-CUF® REUSABLE Blood Pressure Cuff has the same intended use… | 2004 |
| * | — | Critikon Dura-Cuf Named without a submission number |
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 17 years and passes through 2 companies; a new generation was cleared every 15.1 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K022482.
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 | — |
What is it indicated for?
The SURGI-CUF® REUSABLE Blood Pressure Cuff is a bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure. The device is non-sterile and reusable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061962: Surgi-Cuf Reusable, RS Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061962
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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