510(k) Report

510(k) · Cleared

Cleared

Avid-Nit Cervical Regional Anesthesia Needle

K000117510(k) TraditionalCleared Apr 13, 200090-day reviewClass II21 CFR 884.5100

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

Avid Medical, Inc. · HEE Set, Anesthesia, Paracervical

Cleared on Apr 13, 2000 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 13, 2000
Review
90 days
Class
Class II
Product code
HEE
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2005: 1 descendant cleared200020052010201520202025
  1. This deviceK000117 Avid-Nit Cervical Regional Anesthesia NeedleAvid Medical, Inc. · 2000
  2. Descendant · cites it directly · 1 of its ownK021224 Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002
  3. Descendant · 2 generations on · 0 of its ownK052365 Cervineedle Disposable Cartridge SyringeRocket Medical Plc · 2005

Most influential descendants

Showing 2 of 2 · See all
  • K021224Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002 · cites it directly1descendant
  • K052365Cervineedle Disposable Cartridge SyringeRocket Medical Plc · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000117Avid-Nit Cervical Regional Anesthesia NeedleAvid Medical, Inc.2000—
+1K021224Endocervical Block NeedleWallach Surgical Devices, Inc.2002—
+2K052365Cervineedle Disposable Cartridge SyringeRocket Medical Plc2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200510
FIG. 1 — Lineage of K000117, 2000–2005Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HEE? 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K021224Endocervical Block NeedleWallach Surgical Devices, Inc.20021

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?

  • Of its descendants, K021224 (Wallach Surgical Devices, Inc., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HEE devices

HEE Set, Anesthesia, Paracervical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HEE

FDA has decided no HEE device since 2007.

Median 510(k) review, days · HEE

Too few HEE 510(k)s in any year since 2007 to give a median.

Recalls per year · HEE

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HEE

3in 2022

2007: 12016: 12017: 52018: 12019: 32021: 12022: 3
2007high 5 (2017) · low 0 (2008)2025

MAUDE reports naming product code HEE, 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
20070—01
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—10
20160—01
20170—05
20180—01
20190—03
20200—00
20210—01
20220—03
20230—00
20240—00
20250—00
20260—0—

More from Avid Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K001731Avid-Nit Loss of Resistance SyringeAvid Medical, Inc. · 20001 recall

Recent decisions in HEE

The HEE category page

  • K052365Cervineedle Disposable Cartridge SyringeRocket Medical Plc · 2005
  • K021224Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002
  • K983897Cervical Anesthesia Needle, Contracervical Anesthesia Needle, Model #'S 720209 30GAU X 4 MM, 720210 30GAU X…Ri Mos. S.R.L. · 1999
  • K980238Gynex Extended Reach NeedleGynex Corp. · 1998
  • K973671Endocervical Block NeedleA & A Medical, Inc. · 1997

https://510kreport.com/device/K000117 · printed Nov 5, 2026

Cite this page

510(k) Report. “K000117: Avid-Nit Cervical Regional Anesthesia Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000117

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026