510(k) Report

510(k) · Cleared

Cleared

Henschke Afterloading Applicator

K871217510(k) TraditionalCleared Jul 16, 1987112-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 Jul 16, 1987 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.

Decided
Jul 16, 1987
Review
112 days
Class
Class I
Product code
IWJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2020: 1 descendant cleared2014: 1 descendant cleared2012: 2 descendants cleared2015: 2 descendants cleared2024: 1 descendant cleared2025: 2 descendants cleared1990200020102020
  1. This deviceK871217 Henschke Afterloading ApplicatorMick Radio-Nuclear Instruments, Inc. · 1987
  2. Descendant · cites it directly · 7 of its ownK980590 Varisource Henschke Type Gyn Applicator for Varian Varisource Remote…Varian Medical Systems, Inc. · 1998
  3. Descendant · 2 generations on · 3 of its ownK120731 Titanium Fletcher-Style Applicator Set-Defined GeometryVarian Medical Systems, Inc. · 2012
  4. Descendant · cites it directly · 3 of its ownK040704 Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR…Mick Radio-Nuclear Instruments, Inc. · 2004
  5. Descendant · 3 generations on · 2 of its ownK241853 Titanium Fletcher-Style Applicator Set Defined Geometry; Smit…Varian Medical Systems, Inc. · 2024
  6. Descendant · 2 generations on · 2 of its ownK120341 Plastic Needle with Mandrin 2.0 Diameter Length 113MMVarian Medical Systems, Inc. · 2012

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

1998: 12004: 12006: 12012: 22014: 12015: 22020: 12024: 12025: 2
1998high 2 (2012) · low 0 (1999)2026

Most influential descendants

Showing 5 of 12 · See all
  • K980590Varisource Henschke Type Gyn Applicator for Varian Varisource Remote High Dose Rate…Varian Medical Systems, Inc. · 1998 · cites it directly7descendants
  • K120731Titanium Fletcher-Style Applicator Set-Defined GeometryVarian Medical Systems, Inc. · 2012 · 2 generations on3descendants
  • K040704Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix ApplicatorMick Radio-Nuclear Instruments, Inc. · 2004 · cites it directly3descendants
  • K241853Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical SleeveVarian Medical Systems, Inc. · 2024 · 3 generations on2descendants
  • K120341Plastic Needle with Mandrin 2.0 Diameter Length 113MMVarian Medical Systems, Inc. · 2012 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K871217Henschke Afterloading ApplicatorMick Radio-Nuclear Instruments, Inc.1987—
+1K980590Varisource Henschke Type Gyn Applicator for Varian Varisource Remote High Dose…Varian Medical Systems, Inc.1998—
+2K120731Titanium Fletcher-Style Applicator Set-Defined GeometryVarian Medical Systems, Inc.2012—
+1K040704Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix…Mick Radio-Nuclear Instruments, Inc.2004—
+3K241853Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical SleeveVarian Medical Systems, Inc.2024—
+2K120341Plastic Needle with Mandrin 2.0 Diameter Length 113MMVarian Medical Systems, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200410
200610
201220
201410
201520
202010
202410
202520
FIG. 1 — Lineage of K871217, 1987–2025Source: 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
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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? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K980590Varisource Henschke Type Gyn Applicator for Varian Varisource Remote High Dose Rate…Varian Medical Systems, Inc.19987
K040704Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix ApplicatorMick Radio-Nuclear Instruments, Inc.20043

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, K980590 (Varian Medical Systems, Inc., 1998) has gone furthest, with 7 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/K871217 · printed Nov 6, 2026

Cite this page

510(k) Report. “K871217: Henschke Afterloading Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K871217

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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