510(k) Report

510(k) · Cleared

Cleared

Various Template Applicators

K910862510(k) TraditionalCleared Apr 18, 199148-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

Best Industries · IWJ System, Applicator, Radionuclide, Manual

Cleared on Apr 18, 1991 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Apr 18, 1991
Review
48 days
Class
Class I
Product code
IWJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2000: 1 descendant cleared2016: 1 descendant cleared1990200020102020
  1. This deviceK910862 Various Template ApplicatorsBest Industries · 1991
  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 · cites it directly · 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 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K910862Various Template ApplicatorsBest Industries1991—
+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—
+1K031273Ameritek 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 K910862, 1991–2016Source: 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? (3)

2 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
K031273Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc.20030

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—

More from Best Industries

9 FDA decisions under this applicant name. See the company

  • K940119Royal Marsden Gold Grain GunBest Industries · 1994
  • K933410Implant Applicators, Cartridges/Magazines, Implanters for Permanent Implant of Radioactive Seeds/SourcesBest Industries · 1994
  • K940121Implanters/Adjustable/Anderson's MarkersBest Industries · 1994
  • K932242Radioactive Samarium 145 Seeds/Sources #2341-2345Best Industries · 1993
  • K924261Radioactive Cesium-131 Seeds/SourcesBest Industries · 1993

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/K910862 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910862: Various Template Applicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910862

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