510(k) Report

510(k) · Cleared

Cleared

MPS Acacia Nerve Block Needle

K052946510(k) TraditionalCleared Dec 8, 200549-day reviewClass II21 CFR 868.5140

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mps Acacia · CAZ Anesthesia Conduction Kit

Cleared on Dec 8, 2005 as substantially equivalent to K041843 (Epimed International, Inc., 2004) and 2 other predicates after a 49-day review. Its family tree reaches back 3 generations to 1993. 2 of the 14 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided
Dec 8, 2005
Review
49 days
Class
Class II
Product code
CAZ
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K932249 (1993). 12 ancestors in all, the oldest K840287 (1984). 1 later device descends from it, 1 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor1992: 2 other ancestors, 1 with a Class I recall11991: 1 other ancestor, 1 with a Class I recall11984: 1 other ancestor2012: 1 descendant clearedK932249 · Durasafe B-D Combined Spinal Epidural Anesthesia · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1993K954953 · B-D Durasafe Combined Spinal Epidural (Cse) Tray · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1996K040965 · Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles · Pajunk GmbH · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors, 2 with a Class I recall2 1 generation forward: 1 descendant K040965 · Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles · Pajunk GmbH · 2004K954953 · B-D Durasafe Combined Spinal Epidural (Cse) Tray · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1996K932249 · Durasafe B-D Combined Spinal Epidural Anesthesia · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19930
  1. Root · 3 generations backK932249 Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
  2. 2 generations backK954953 B-D Durasafe Combined Spinal Epidural (Cse) TrayBd Becton Dickinson Vacutainer Systems Preanalytic · 1996
  3. 1 generation backK040965 Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford…Pajunk GmbH · 2004
  4. This deviceK052946 MPS Acacia Nerve Block NeedleMps Acacia · 2005
  5. Descendant · cites it directly · 0 of its ownK113662 Fenestrated Nerve Block NeedleImd, Inc. · 2012

Class I recalls in this family

Most influential descendants

Showing 1 of 1 · See all
  • K113662Fenestrated Nerve Block NeedleImd, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K932249Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic1993—
−2K954953B-D Durasafe Combined Spinal Epidural (Cse) TrayBd Becton Dickinson Vacutainer Systems Preanalytic1996—
−1K040965Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesPajunk GmbH2004—
0 (this device)K052946MPS Acacia Nerve Block NeedleMps Acacia2005—
+1K113662Fenestrated Nerve Block NeedleImd, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199111
199221
199310
199510
200010
200210
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K052946, 1993–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261372 Profoject™ LOR Syringescore 12.4 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K041843Pencil Point Needle
Summary page 1
…de name: Nerve Block Needle Common name: Nerve Block Needle 5. Predicate device: Blunt Nerve Block Needle 510(k) number: K041843 Marketed by: Epimed International 141 Sal Landrio Drive…
Epimed International, Inc.20041
*K040965Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles
Summary page 1
…141 Sal Landrio Drive Johnstown, NY 12095 Predicate device: Pajunk Anesthesia Conduction Needle 510(k) number: K040965 Marketed by: Pajunk Medical Technology Karl-Hall-Str. 1…
Pajunk GmbH2004—
*K013041Plexolong Sets
Summary page 1
…all-Str. 1 78187 Geisingen Germany Predicate device: Plexolong Set 510(k) number: K013041 Marketed by: Pajunk Medical Technology Karl-Hall-Str. 1…
Pajunk GmbH2002—

Also cleared against K041843: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113662Fenestrated Nerve Block NeedleImd, Inc.20120

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.

  • K911202Atraumatic Standard Sprotte NeedlePajunk GmbH · 1992 · 2 generations back · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
  • K911260Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · 2 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • 3 of the 12 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K113662 (Imd, Inc., 2012) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K041843.

How does its category compare?

All CAZ devices

CAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAZ

1in 2023

2007: 42008: 42009: 22010: 22011: 12012: 92015: 12016: 22019: 12020: 12021: 12022: 12023: 12026 (partial year): 1
2007high 9 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAZ

108in 2012

2007: 172 days median2008: 99 days median2012: 108 days median
2007high 172 (2007) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAZ

1in 2024

2009: 292010: 82011: 22013: 122014: 22015: 12016: 12024: 12026 (partial year): 12, 11 Class I
2007high 29 (2009) · low 0 (2007)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · CAZ

137in 2025

2007: 812008: 802009: 1342010: 1392011: 1872012: 1872013: 2762014: 2512015: 2352016: 3722017: 3532018: 4482019: 4722020: 2742021: 1652022: 2702023: 602024: 1652025: 137
2007high 472 (2019) · low 60 (2023)2025

MAUDE reports naming product code CAZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074172081
2008499080
20092—29134
20102—8139
20111—2187
201291080187
20130—12276
20140—2251
20151—1235
20162—1372
20170—0353
20180—0448
20191—0472
20201—0274
20211—0165
20221—0270
20231—060
20240—1165
20250—0137
20261—12 (11)—

What is it indicated for?

1. The MPS Acacia Nerve Block Needle is intended for the administration of local anesthetic agents to provide regional anesthesia or the administration of anti-inflammatory medication to relieve chronic pain conditions, or to facilitate placement of a catheter. 2. The MPS Acacia Nerve Block Stimulating Needle version is also intended to aid in locating specific peripheral nerves or nerve plexuses for the precise delivery of local anesthetic agents or…

Read the full statement (113 words)

1. The MPS Acacia Nerve Block Needle is intended for the administration of local anesthetic agents to provide regional anesthesia or the administration of anti-inflammatory medication to relieve chronic pain conditions, or to facilitate placement of a catheter.

2. The MPS Acacia Nerve Block Stimulating Needle version is also intended to aid in locating specific peripheral nerves or nerve plexuses for the precise delivery of local anesthetic agents or anti-inflammatory medication for the relief of chronic pain conditions or to provide regional anesthesia, or to facilitate placement of a catheter.

3. Routes of administration may include Peripheral nerve blocks, Sympathetic blocks, Selective nerve blocks, Intra-articular injections (i.e. Facet blocks), Interlaminar and Transforaminal approaches.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K052946: MPS Acacia Nerve Block Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052946

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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