510(k) Report

510(k) · Cleared

Cleared

Cesium 137 Source, Model CSM-40

K882449510(k) TraditionalCleared Apr 14, 1989304-day reviewClass II21 CFR 892.5730

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cis-Us, Inc. · IWI Source, Isotope, Sealed, Gold, Titanium, Platinum

Cleared on Apr 14, 1989 after a 304-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 14, 1989
Review
304 days
Class
Class II
Product code
IWI
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K882449Source: FDA 510(k) database · 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.

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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All IWI devices

IWI Source, Isotope, Sealed, Gold, Titanium, Platinum: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IWI

FDA has decided no IWI device since 2007.

Median 510(k) review, days · IWI

Too few IWI 510(k)s in any year since 2007 to give a median.

Recalls per year · IWI

No recall names IWI since 2007.

Adverse event reports per year · IWI

1in 2015

2013: 22015: 1
2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code IWI, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—02
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Cis-Us, Inc.

9 FDA decisions under this applicant name. See the company

  • K951708Elsa-HCTCis-Us, Inc. · 1995
  • K950211Elsa-PTHCis-Us, Inc. · 1995
  • K890799Curietron 192 High Dose RateCis-Us, Inc. · 1989
  • K871502Personnel Protective ShieldCis-Us, Inc. · 1987
  • K865027Irradiator for Biological Materials, Ibl-137CCis-Us, Inc. · 1987

Recent decisions in IWI

The IWI category page

  • K973363North American Scientific (Nasi)PD-103 Radionuclide Brachytherapy Source-Model MED3633Ml Strategies, Inc. · 1998
  • K940632I-125 Rapid StrandMedi-Physics Inc. Dba Nycomed Amersham Imaging · 1994
  • K912170Radioactive Iodine-125 SourcesBest Industries · 1991
  • K874787Modified Palladium Seed Model 100Theragenics Corp. · 1987
  • K852542Palladium Seed Model 100Nuclear Medicine, Inc. · 1986

https://510kreport.com/device/K882449 · printed Nov 5, 2026

Cite this page

510(k) Report. “K882449: Cesium 137 Source, Model CSM-40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K882449

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026