510(k) Report

510(k) · Cleared

Cleared

Medi/Nuclear #XE-102 Xenon/Master

K810819510(k) TraditionalCleared Apr 14, 198121-day reviewClass II21 CFR 892.1390

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

Medi Nuclear Corp., Inc. · IYT System, Rebreathing, Radionuclide

Cleared on Apr 14, 1981 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Apr 14, 1981
Review
21 days
Class
Class II
Product code
IYT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2026: 1 descendant cleared19801990200020102020
  1. This deviceK810819 Medi/Nuclear #XE-102 Xenon/MasterMedi Nuclear Corp., Inc. · 1981
  2. Descendant · cites it directly · 0 of its ownK253942 Pulmonex II Xenon System (132-503)Mirion Technologies (Capintec), Inc. · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K253942Pulmonex II Xenon System (132-503)Mirion Technologies (Capintec), Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K810819Medi/Nuclear #XE-102 Xenon/MasterMedi Nuclear Corp., Inc.1981—
+1K253942Pulmonex II Xenon System (132-503)Mirion Technologies (Capintec), Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K810819, 1981–2026Source: 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 IYT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYT device

  1. #1 K253942 Pulmonex II Xenon System (132-503)score 11.6 · 1 generation · no Class I recall
  2. #2 Held for the reportin 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K253942Pulmonex II Xenon System (132-503)Mirion Technologies (Capintec), Inc.20260

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, K253942 (Mirion Technologies (Capintec), Inc., 2026) has gone furthest, with 0 descendants of its own.

How does its category compare?

All IYT devices

IYT System, Rebreathing, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYT

1in 2020

2020: 12026 (partial year): 1
2007high 1 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYT

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

Recalls per year · IYT

No recall names IYT since 2007.

Adverse event reports per year · IYT

2in 2025

2012: 12013: 22021: 12023: 22025: 2
2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code IYT, 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—01
20130—02
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20201—00
20210—01
20220—00
20230—02
20240—00
20250—02
20261—0—

More from Medi Nuclear Corp., Inc.

9 FDA decisions under this applicant name. See the company

  • K082541Healthline Medicator / Redineb Aerosol Drug Delivery SystemMedi Nuclear Corp., Inc. · 2008
  • K080969Healthline Redi-Neb Medication Nebulizer, Model RN-510Medi Nuclear Corp., Inc. · 2008
  • K080657Neb-90 Large Volume Medication NebulizerMedi Nuclear Corp., Inc. · 2008
  • K915075Nebulizer (Direct Patient Interface)Medi Nuclear Corp., Inc. · 1992
  • K865107Aero-Vent Aerosol UnitMedi Nuclear Corp., Inc. · 1987

Recent decisions in IYT

The IYT category page

  • K253942Pulmonex II Xenon System (132-503)Mirion Technologies (Capintec), Inc. · 2026
  • K200916Patient Administration SetCyclomedica Australia Pty, Ltd. · 2020
  • K953513Xenon CircuitKing Systems Corp. · 1995
  • K952223Xenon Gas Breathing CircuitIntertech Resources, Inc. · 1995
  • K914747Xenon CircuitGibeck, Inc. · 1992

https://510kreport.com/device/K810819 · printed Nov 6, 2026

Cite this page

510(k) Report. “K810819: Medi/Nuclear #XE-102 Xenon/Master.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810819

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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