510(k) · Cleared
ClearedFlexiport Ecocuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · DXQ Blood Pressure Cuff
Cleared on Nov 5, 2012 as substantially equivalent to K070060 (Welch Allyn, Inc., 2007) after a 115-day review. Its family tree reaches back 3 generations to 1979.
- Decided
- Nov 5, 2012
- Review
- 115 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K790810 (1979). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
- 2 generations backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- 1 generation backK070060 Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece)…Welch Allyn, Inc. · 2007 · Recalled
- This deviceK122058 Flexiport EcocuffWelch Allyn, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K790810 | Disposa-Cuf | Crest Medical Equipment | 1979 | — |
| −2 | K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. | 1998 | 1 |
| −1 | K070060 | Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable… | Welch Allyn, Inc. | 2007 | 1 |
| 0 (this device) | K122058 | Flexiport Ecocuff | Welch Allyn, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K070060 | Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood…Summary page 1…870.1120 Classification Product Code: DXQ Predicate Devices: Welch Allyn Flexiort Blood Pressure Cuff 510(k) Number K070060 Indications for Use: The Flexiort Ecouff Blood Pressure Cuff is intended to be used on the upper arm in conjunction with noni… | 2007 |
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 33 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K070060.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Flexiort Ecouff Blood Pressure Cuff is intended to be used on the upper arm in conjunction with noninvasive blood pressure measurement systems. The cuff is nonsterile and is available in pediatric through adult sizes. The device is not intended for neonatal applications. The Flexiport Ecouff blood pressure cuff is not designed, sold or intended for use, except as indicated.
This product is available for sale only upon the order of a physician or licensed health care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122058: Flexiport Ecocuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122058
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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