510(k) · Cleared
ClearedCuff-Able Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Signs, Inc. · DXQ Blood Pressure Cuff
Cleared on Sep 1, 1999 as substantially equivalent to K884421 (Pymah Corp., 1989) and 1 other predicate after a 203-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Sep 1, 1999
- Review
- 203 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K884421 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK884421 Pre-Gaged Balanced Cuff W/Sylgard Antimicro. TreatPymah Corp. · 1989
- This deviceK990412 Cuff-Able PlusVital Signs, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884421 | Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat | Pymah Corp. | 1989 | — |
| 0 (this device) | K990412 | Cuff-Able Plus | Vital Signs, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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? (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 |
|---|---|---|---|
| * | K884421 | Pre-Gaged Balanced Cuff W/Sylgard Antimicro. TreatSummary page 1…irs August 12, 1999 CUFF-ABLE PLUS™ Blood Pressure Cuff Non-Automated Sphygmomanometers (per CFR 870.1120) PyMaH Corp., Pregaged® Cuff with Antimicrobial Treatment - K884421 Vital Signs, Inc., CUFF-ABLE® (Biomedical Dynamics- K911213) The device comprises a soft fabric with an integral bladder that i… | 1989 |
| * | K911213 | CuffableSummary page 1…n-Automated Sphygmomanometers (per CFR 870.1120) PyMaH Corp., Pregaged® Cuff with Antimicrobial Treatment - K884421 Vital Signs, Inc., CUFF-ABLE® (Biomedical Dynamics- K911213) The device comprises a soft fabric with an integral bladder that is wrapped around a patient’s limb and secured by a hook and l… | 1991 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K884421.
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 CUFF-ABLE PLUS™ blood pressure cuff is used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the usc of mannal and automatic sphygmomanometers. The device is non-sterile and is intended as a single patient use disposable device and is available in child and adult sizes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990412 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990412: Cuff-Able Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990412
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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