510(k) · Decided
DecidedKendall Blunt Tuohy Epidural Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall Healthcare Products Co. Div.Of Tyco Health · CAZ Anesthesia Conduction Kit
Cleared on May 30, 1996 as substantially equivalent to K921288 (Kendall Healthcare Products Co. Div.Of Tyco Health, 1993) after a 231-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- May 30, 1996
- Review
- 231 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921288 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK921288 Curity Calibrated Tuohy Type Epidural NeedleKendall Healthcare Products Co. Div.Of Tyco Health · 1993
- This deviceK954706 Kendall Blunt Tuohy Epidural NeedleKendall Healthcare Products Co. Div.Of Tyco Health · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921288 | Curity Calibrated Tuohy Type Epidural Needle | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993 | — |
| 0 (this device) | K954706 | Kendall Blunt Tuohy Epidural Needle | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996 | — |
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 CAZ? 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 CAZ device
- #1 K261372 Profoject™ LOR Syringescore 12.4 · 2 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 |
|---|---|---|---|
| * | K921288 | Curity Calibrated Tuohy Type Epidural NeedleSummary page 1…ral Needle is substantially equivalent in composition, form, function and intended use to the commercially available - Kendall 18 Gauge Calibrated Tuohy Epidural Needle (K921288B). 4, Device Description The Kendall Blunt Tip Tuohy Epidural Needle is a sterile single use device designed to be used for the… | 1993 |
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?
- Its one ancestor has no recall.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CAZ
108in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAZ
1in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · CAZ
137in 2025
MAUDE reports naming product code CAZ, 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 | 4 | 172 | 0 | 81 |
| 2008 | 4 | 99 | 0 | 80 |
| 2009 | 2 | — | 29 | 134 |
| 2010 | 2 | — | 8 | 139 |
| 2011 | 1 | — | 2 | 187 |
| 2012 | 9 | 108 | 0 | 187 |
| 2013 | 0 | — | 12 | 276 |
| 2014 | 0 | — | 2 | 251 |
| 2015 | 1 | — | 1 | 235 |
| 2016 | 2 | — | 1 | 372 |
| 2017 | 0 | — | 0 | 353 |
| 2018 | 0 | — | 0 | 448 |
| 2019 | 1 | — | 0 | 472 |
| 2020 | 1 | — | 0 | 274 |
| 2021 | 1 | — | 0 | 165 |
| 2022 | 1 | — | 0 | 270 |
| 2023 | 1 | — | 0 | 60 |
| 2024 | 0 | — | 1 | 165 |
| 2025 | 0 | — | 0 | 137 |
| 2026 | 1 | — | 12 (11) | — |
What is it indicated for?
Like other commercially available epidural needles, the Kendall Blunt Tip Tuohy Epidural Needle is used to administer anesthetic to the peridural space.
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/K954706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954706: Kendall Blunt Tuohy Epidural Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954706
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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