510(k) Report

510(k) · Cleared

Cleared

Hilaris-Nori Cervix Applicator

K891377510(k) TraditionalCleared Apr 14, 198936-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 Apr 14, 1989 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Apr 14, 1989
Review
36 days
Class
Class I
Product code
IWJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared2006: 1 descendant cleared2020: 1 descendant cleared2014: 1 descendant cleared1990200020102020
  1. This deviceK891377 Hilaris-Nori Cervix ApplicatorMick Radio-Nuclear Instruments, Inc. · 1989
  2. Descendant · cites it directly · 3 of its ownK040704 Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR…Mick Radio-Nuclear Instruments, Inc. · 2004
  3. Descendant · 2 generations on · 1 of its ownK063381 CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc. · 2006
  4. Descendant · 2 generations on · 0 of its ownK200221 CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem…Mick Radio-Nuclear Instruments, Inc. · 2020
  5. Descendant · 2 generations on · 0 of its ownK141343 Axxent Cervical ApplicatorIcad, Inc. · 2014

Most influential descendants

Showing 4 of 4 · See all
  • K040704Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix ApplicatorMick Radio-Nuclear Instruments, Inc. · 2004 · cites it directly3descendants
  • K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc. · 2006 · 2 generations on1descendant
  • K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc. · 2020 · 2 generations on0descendants
  • K141343Axxent Cervical ApplicatorIcad, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K891377Hilaris-Nori Cervix ApplicatorMick Radio-Nuclear Instruments, Inc.1989—
+1K040704Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix…Mick Radio-Nuclear Instruments, Inc.2004—
+2K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc.2006—
+2K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid…Mick Radio-Nuclear Instruments, Inc.2020—
+2K141343Axxent Cervical ApplicatorIcad, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
201410
202010
FIG. 1 — Lineage of K891377, 1989–2020Source: 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 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? (4)

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

NumberDeviceApplicantDecidedDescendants
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, K040704 (Mick Radio-Nuclear Instruments, Inc., 2004) has gone furthest, with 3 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/K891377 · printed Nov 4, 2026

Cite this page

510(k) Report. “K891377: Hilaris-Nori Cervix Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891377

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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