510(k) Report

510(k) · Cleared

Cleared

Prostate Seeding Needle

K973184510(k) TraditionalCleared Nov 21, 199788-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

Promex, Inc. · IWJ System, Applicator, Radionuclide, Manual

Cleared on Nov 21, 1997 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Nov 21, 1997
Review
88 days
Class
Class I
Product code
IWJ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared1995200020052010201520202025
  1. This deviceK973184 Prostate Seeding NeedlePromex, Inc. · 1997
  2. Descendant · cites it directly · 0 of its ownK052435 Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973184Prostate Seeding NeedlePromex, Inc.1997—
+1K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K973184, 1997–2005Source: 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), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050

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, K052435 (Pneumrx, Inc., 2005) has gone furthest, with 0 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—

What is it indicated for?

For the manual application of a radionuclide source into the body for

radiation therapy.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Promex, Inc.

18 FDA decisions under this applicant name. See the company

  • K023450Biopsy Site Tissue Marker DevicePromex, Inc. · 2002
  • K022634CO-Axial Introducer NeedlePromex, Inc. · 20026 recalls
  • K010400Vacuum Assisted Core Biopsy DevicePromex, Inc. · 20015 recalls
  • K011270Automated Core Biopsy DevicePromex, Inc. · 2001
  • K001132Bone Biopsy NeedlePromex, Inc. · 2000

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/K973184 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973184: Prostate Seeding Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973184

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026