510(k) · Cleared
Recalled · Class II · 2025Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood Pressure Cuff (One-Piece)
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 Dec 18, 2007 as substantially equivalent to K974080 (Johnson & Johnson Medical, Inc., 1998) and 1 other predicate after a 347-day review. Its family tree reaches back 2 generations to 1979. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 18, 2007
- Review
- 347 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K790810 (1979). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
- 1 generation backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- This deviceK070060 Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece)…Welch Allyn, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK251745 Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure…Baxter Healthcare Corporation · 2025
- Descendant · cites it directly · 0 of its ownK122058 Flexiport EcocuffWelch Allyn, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K790810 | Disposa-Cuf | Crest Medical Equipment | 1979 | — |
| −1 | K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. | 1998 | 1 |
| 0 (this device) | K070060 | Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable… | Welch Allyn, Inc. | 2007 | — |
| +1 | K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Baxter Healthcare Corporation | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K974080 | Critikon Soft Blood Pressure CuffSummary page 1…e Cuff (One-Piece) Classification Name: Cuff, Blood-Pressure Classification: Class II per 21 CFR 870.1120 Predicate Devices: Critikon Soft Blood Pressure Cuff (K974080) Sensa-Cuff; Models Infant, Child, Adult (K022482) Description: FlexiPortTM Blood Pressure Cuffs ar… | 1998 |
| * | K022482 | Sensa-Cuff, Models Infant, Child, AdultSummary page 1…cation: Class II per 21 CFR 870.1120 Predicate Devices: Critikon Soft Blood Pressure Cuff (K974080) Sensa-Cuff; Models Infant, Child, Adult (K022482) Description: FlexiPortTM Blood Pressure Cuffs are designed with the FlexiPortiM, a standardized co… | 2002 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2025 | Class II | Z-1568-2025 | Device Design | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 19.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K251745 (Baxter Healthcare Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K974080.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 FlexiPort Blood Pressure Cuff is used 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 Blood Pressure Cuffs are not designed, sold, or intended for use, except as indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070060 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070060: Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood Pressure Cuff (One-Piece).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070060
Report an extraction error
Are you the manufacturer?
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