510(k) · Cleared
ClearedUltracheck Curve Blood Pressure Cuffs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Statcorp Medical · OED Antimicrobial Blood Pressure Cuff
Cleared on Jun 4, 2013 as substantially equivalent to K071885 (Philips Medical Systems, 2007) and 1 other predicate after a 302-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jun 4, 2013
- Review
- 302 days
- Class
- Class II
- Product code
- OED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K884421 (1989). 5 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 | K884421 | Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat | Pymah Corp. | 1989 | — |
| −1 | K071885 | Antimicrobial and Single-Patient Cuffs | Philips Medical Systems | 2007 | — |
| 0 (this device) | K122365 | Ultracheck Curve Blood Pressure Cuffs | Statcorp Medical | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 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 OED? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K071885 | Antimicrobial and Single-Patient CuffsSummary page 2…The table below indicates the similarities and differenbes between the UltraCheck® Curve and the predicate devices. New UltraCheck® Philips Philips UltraCheck® Cuffs in K071885 K071885 Curve Cuffs K954282 Models Adult Bariatric | Adult Large Adult Large Adult X-Large BRUS3854 US3544 & M4557B for Thigh BRU… | 2007 |
| * | K954282 | Ultracuff Blood Pressure Cuff and Inflation BagSummary page 1…dicate devices for this cuff are the Philips Series of Multi-Patient Cuffs and Single-. Patient Cuffs, 510(k) # KO71885 and the’ Ultracuff Blood Pressure Cuff, 5 10(k) # K954282. Statcorp Medical Attachment 2 Page 1 of 4 K122365 IV. General Description The UltraCheck® Blood Pressure cuf… | 1996 |
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 24 years and passes through 3 companies; a new generation was cleared every 18.9 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K071885.
How does its category compare?
All OED devicesOED Antimicrobial Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OED
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · OED
Too few OED 510(k)s in any year since 2007 to give a median.
Recalls per year · OED
No recall names OED since 2007.
Adverse event reports per year · OED
8in 2025
MAUDE reports naming product code OED, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
UltraCheck® Curve Blood Pressure Cuffs are used with identified devices intended for the non-invasive measurement of adult human blood pressure.
UltraCheck® Blood Pressure Cuffs are intended for use by or under the supervision of qualified medical personnel.
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/K122365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122365: Ultracheck Curve Blood Pressure Cuffs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122365
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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