510(k) Report

510(k) · Cleared

Cleared

Needle Technologies Seed Implant Needle

K921886510(k) TraditionalCleared Oct 5, 1992167-day reviewClass I21 CFR 892.5650

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

Needle Technologies, Inc. · IWJ System, Applicator, Radionuclide, Manual

Cleared on Oct 5, 1992 after a 167-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Oct 5, 1992
Review
167 days
Class
Class I
Product code
IWJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2000: 1 descendant cleared2003: 1 descendant cleared2016: 1 descendant cleared1990200020102020
  1. This deviceK921886 Needle Technologies Seed Implant NeedleNeedle Technologies, Inc. · 1992
  2. Descendant · cites it directly · 2 of its ownK993400 HDR Contour TP Template and Implant AccessoriesMick Radio-Nuclear Instruments, Inc. · 2000
  3. Descendant · 2 generations on · 0 of its ownK150979 CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. · 2016
  4. Descendant · 2 generations on · 0 of its ownK031273 Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003

Most influential descendants

Showing 3 of 3 · See all
  • K993400HDR Contour TP Template and Implant AccessoriesMick Radio-Nuclear Instruments, Inc. · 2000 · cites it directly2descendants
  • K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. · 2016 · 2 generations on0descendants
  • K031273Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921886Needle Technologies Seed Implant NeedleNeedle Technologies, Inc.1992—
+1K993400HDR Contour TP Template and Implant AccessoriesMick Radio-Nuclear Instruments, Inc.2000—
+2K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc.2016—
+2K031273Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200310
201610
FIG. 1 — Lineage of K921886, 1992–2016Source: 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.

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  • 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K993400HDR Contour TP Template and Implant AccessoriesMick Radio-Nuclear Instruments, Inc.20002

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, K993400 (Mick Radio-Nuclear Instruments, Inc., 2000) has gone furthest, with 2 descendants of its own.

How does its category compare?

All IWJ devices

IWJ System, Applicator, Radionuclide, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IWJ

FDA has decided no IWJ device since 2007.

Median 510(k) review, days · IWJ

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

Recalls per year · IWJ

1in 2019

2007: 52009: 12011: 12018: 22019: 1
2007high 5 (2007) · low 0 (2008)2026

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

Adverse event reports per year · IWJ

40in 2025

2008: 32009: 32010: 12013: 72014: 42015: 22016: 22017: 72018: 32019: 52020: 52021: 152022: 32023: 12024: 22025: 40
2007high 40 (2025) · low 0 (2007)2025

MAUDE reports naming product code IWJ, 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—50
20080—03
20090—13
20100—01
20110—10
20120—00
20130—07
20140—04
20150—02
20160—02
20170—07
20180—23
20190—15
20200—05
20210—015
20220—03
20230—01
20240—02
20250—040
20260—0—

Recent decisions in IWJ

The IWJ category page

  • K010166Imagyn Isosleeve / Isostar Needle SystemImagyn Medical Technologies, Inc. · 2001
  • K980997PGK Device (Modified)Pgk, Inc. · 1998
  • K972554Reganes Radionuclide Seed MagazineAvid N.I.T., Inc. · 1998
  • K973037N.I.T., Inc. Radionuclide Seed Applicator, Model SA-1000Avid N.I.T., Inc. · 1998
  • K974118Worldwide Medical Technologies Seed Implant Needle SetWorldwide Medical Technologies, LLC · 1998

https://510kreport.com/device/K921886 · printed Nov 5, 2026

Cite this page

510(k) Report. “K921886: Needle Technologies Seed Implant Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K921886

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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