510(k) Report

510(k) · Cleared

Recalled · 2005

Mick 200-TP and Mick TP Needle

K890341510(k) TraditionalCleared Mar 14, 198950-day reviewClass I21 CFR 892.5650Recalls 1

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

Mick Radio-Nuclear Instruments, Inc. · IWJ System, Applicator, Radionuclide, Manual

Cleared on Mar 14, 1989 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled once.

Decided
Mar 14, 1989
Review
50 days
Class
Class I
Product code
IWJ
Recalls
1
Predicates
0

7 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared1999: 1 descendant cleared2007: 1 descendant cleared2000: 1 descendant cleared2014: 1 descendant cleared2003: 1 descendant cleared2016: 1 descendant cleared1990200020102020
  1. This deviceK890341 Mick 200-TP and Mick TP NeedleMick Radio-Nuclear Instruments, Inc. · 1989
  2. Descendant · cites it directly · 2 of its ownK993400 HDR Contour TP Template and Implant AccessoriesMick Radio-Nuclear Instruments, Inc. · 2000
  3. Descendant · cites it directly · 1 of its ownK051423 Mick HDR Interstitial Implant AccessoriesMick Radio-Nuclear Instruments, Inc. · 2005
  4. Descendant · 2 generations on · 0 of its ownK150979 CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. · 2016
  5. Descendant · 2 generations on · 0 of its ownK130757 Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer…Spencer Fillmore · 2014
  6. Descendant · cites it directly · 0 of its ownK072296 Poiint of Care Stranding System, Mode 1004-00Theragenics Corp. · 2007 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12003: 12005: 12007: 12014: 12016: 1
1999high 1 (1999) · low 0 (2001)2026

Most influential descendants

Showing 5 of 7 · See all
  • K993400HDR Contour TP Template and Implant AccessoriesMick Radio-Nuclear Instruments, Inc. · 2000 · cites it directly2descendants
  • K051423Mick HDR Interstitial Implant AccessoriesMick Radio-Nuclear Instruments, Inc. · 2005 · cites it directly1descendant
  • K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. · 2016 · 2 generations on0descendants
  • K130757Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube SetSpencer Fillmore · 2014 · 2 generations on0descendants
  • K072296Poiint of Care Stranding System, Mode 1004-00Theragenics Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K890341Mick 200-TP and Mick TP NeedleMick Radio-Nuclear Instruments, Inc.1989—
+1K993400HDR Contour TP Template and Implant AccessoriesMick Radio-Nuclear Instruments, Inc.2000—
+1K051423Mick HDR Interstitial Implant AccessoriesMick Radio-Nuclear Instruments, Inc.2005—
+2K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc.2016—
+2K130757Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube SetSpencer Fillmore2014—
+1K072296Poiint of Care Stranding System, Mode 1004-00Theragenics Corp.20071

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200310
200510
200710
201410
201610
FIG. 1 — Lineage of K890341, 1989–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 IWJ? 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

4 later devices cite 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
K051423Mick HDR Interstitial Implant AccessoriesMick Radio-Nuclear Instruments, Inc.20051
K072296Poiint of Care Stranding System, Mode 1004-00Theragenics Corp.20070
K992262Indigo Prostate Seeding Needle Cartridge SystemIndigo Medical, Inc.19990

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 30, 2005Not classifiedZ-0857-05OtherSome of the Mick TP Prostate Seeding Needles do not fit properly into the Mick 200-TPV Applicator. Firm received one complaint during use of the Mick 200 TPV Applicator.

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—

More from Mick Radio-Nuclear Instruments, Inc.

43 FDA decisions under this applicant name. See the company

  • K230155Mick Valencia Applicator SetMick Radio-Nuclear Instruments, Inc. · 2023
  • K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT…Mick Radio-Nuclear Instruments, Inc. · 2020
  • K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. · 2016
  • K142597Vienna SystemMick Radio-Nuclear Instruments, Inc. · 2015
  • K122840CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407Mick Radio-Nuclear Instruments, Inc. · 2012

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/K890341 · printed Nov 5, 2026

Cite this page

510(k) Report. “K890341: Mick 200-TP and Mick TP Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K890341

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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