510(k) · Cleared
ClearedFenestrated Nerve Block Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imd, Inc. · CAZ Anesthesia Conduction Kit
Cleared on Apr 20, 2012 as substantially equivalent to K052946 (Mps Acacia, 2005) and 1 other predicate after a 135-day review. Its family tree reaches back 4 generations to 1993. 2 of the 15 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 20, 2012
- Review
- 135 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K932249 (1993). 14 ancestors in all, the oldest K840287 (1984). No later device cites it as a predicate yet. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK932249 Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 3 generations backK954953 B-D Durasafe Combined Spinal Epidural (Cse) TrayBd Becton Dickinson Vacutainer Systems Preanalytic · 1996
- 2 generations backK040965 Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford…Pajunk GmbH · 2004
- 1 generation backK052946 MPS Acacia Nerve Block NeedleMps Acacia · 2005
- This deviceK113662 Fenestrated Nerve Block NeedleImd, Inc. · 2012
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932249 | Durasafe B-D Combined Spinal Epidural Anesthesia | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −3 | K954953 | B-D Durasafe Combined Spinal Epidural (Cse) Tray | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1996 | — |
| −2 | K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles | Pajunk GmbH | 2004 | — |
| −1 | K052946 | MPS Acacia Nerve Block Needle | Mps Acacia | 2005 | — |
| 0 (this device) | K113662 | Fenestrated Nerve Block Needle | Imd, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1991 | 1 | 1 |
| 1992 | 2 | 1 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 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.
2 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K052946 | MPS Acacia Nerve Block NeedleSummary page 1…Block Needle; Product Code. CAZ (BSP, MEB) Regulation Nos.: 868.5140 (868.5150, 880.5725) 02. PREDICATE DEVICES: e MPS Acacia Nerve Block Needle, K052946, cleared 12/08/2005; e Life-Tech's Peripheral Nerve Block Support Tray, K073 187, cleared 04/22/2008. See also th… | 2005 |
| * | K073187 | Peripheral Nerve Block Support TraySummary page 1…5150, 880.5725) 02. PREDICATE DEVICES: e MPS Acacia Nerve Block Needle, K052946, cleared 12/08/2005; e Life-Tech's Peripheral Nerve Block Support Tray, K073 187, cleared 04/22/2008. See also the FDA's 5 10(k) database of several other products under the same or similar class… | 2008 |
| † | K070354 | Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point) | 2007 |
| † | K931644 | Gertie Marx Needle | 1993 |
| † | K030830 | B. Braun Nerve Block Catheter | 2003 |
| † | K991543 | Intraop Catheter | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 14 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
IMD's New Fenestrated Nerve Block Needle is a single patient use needle to provide local or regional nerve blocking by the injecting of a local anesthesia.
It is to be used only under the direction of a licensed clinician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113662: Fenestrated Nerve Block Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113662
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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