510(k) Report

510(k) · Cleared

Cleared

Quick Seeder

K913293510(k) TraditionalCleared Oct 13, 1992447-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

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

Cleared on Oct 13, 1992 after a 447-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.

Decided
Oct 13, 1992
Review
447 days
Class
Class I
Product code
IWJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 3 descendants cleared2001: 1 descendant cleared1997: 1 descendant cleared1990200020102020
  1. This deviceK913293 Quick SeederMick Radio-Nuclear Instruments, Inc. · 1992
  2. Descendant · cites it directly · 4 of its ownK972152 Devmed Stepping and Stabilizing SystemDevmed Corp. · 1997
  3. Descendant · cites it directly · 3 of its ownK011581 Ameritek Brachytherapy TemplateAmertek Medical, Inc. · 2001
  4. Descendant · 2 generations on · 0 of its ownK031273 Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003
  5. Descendant · cites it directly · 0 of its ownK030518 Ameritek Sure-Point Tracker SystemAmertek Medical, Inc. · 2003
  6. Descendant · cites it directly · 0 of its ownK024183 Alton PT StepperAlton Design, LLC · 2003

Most influential descendants

Showing 5 of 5 · See all
  • K972152Devmed Stepping and Stabilizing SystemDevmed Corp. · 1997 · cites it directly4descendants
  • K011581Ameritek Brachytherapy TemplateAmertek Medical, Inc. · 2001 · cites it directly3descendants
  • K031273Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003 · 2 generations on0descendants
  • K030518Ameritek Sure-Point Tracker SystemAmertek Medical, Inc. · 2003 · cites it directly0descendants
  • K024183Alton PT StepperAlton Design, LLC · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913293Quick SeederMick Radio-Nuclear Instruments, Inc.1992—
+1K972152Devmed Stepping and Stabilizing SystemDevmed Corp.1997—
+1K011581Ameritek Brachytherapy TemplateAmertek Medical, Inc.2001—
+2K031273Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc.2003—
+1K030518Ameritek Sure-Point Tracker SystemAmertek Medical, Inc.2003—
+1K024183Alton PT StepperAlton Design, LLC2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200110
200330
FIG. 1 — Lineage of K913293, 1992–2003Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (5)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972152Devmed Stepping and Stabilizing SystemDevmed Corp.19974
K011581Ameritek Brachytherapy TemplateAmertek Medical, Inc.20013
K030518Ameritek Sure-Point Tracker SystemAmertek Medical, Inc.20030
K024183Alton PT StepperAlton Design, LLC20030

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, K972152 (Devmed Corp., 1997) has gone furthest, with 4 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/K913293 · printed Nov 4, 2026

Cite this page

510(k) Report. “K913293: Quick Seeder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K913293

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