510(k) Report

510(k) · Cleared

Cleared

RT-200 Calibration Analyzer

K822746510(k) TraditionalCleared Oct 13, 198233-day reviewClass I21 CFR 868.2620

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

Timeter Instrument Corp. · BXX Calibrator, Pressure, Gas

Cleared on Oct 13, 1982 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 13, 1982
Review
33 days
Class
Class I
Product code
BXX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822746Source: 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.

Planning a device in BXX? 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?

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 BXX devices

BXX Calibrator, Pressure, Gas: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BXX

FDA has decided no BXX device since 2007.

Median 510(k) review, days · BXX

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

Recalls per year · BXX

No recall names BXX since 2007.

Adverse event reports per year · BXX

2in 2012

2010: 12012: 2
2007high 2 (2012) · low 0 (2007)2025

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

More from Timeter Instrument Corp.

29 FDA decisions under this applicant name. See the company

  • K875075RT-200 Computer InterfaceTimeter Instrument Corp. · 1988
  • K875074Vacumate Intermittent/Continuous Controller,VM2000Timeter Instrument Corp. · 1988
  • K871603Criterion II & Iia Oxygen ConcentratorsTimeter Instrument Corp. · 1987
  • K864836L.a.P. SpirometerTimeter Instrument Corp. · 1987
  • K834274Criterion ITimeter Instrument Corp. · 1984

Recent decisions in BXX

The BXX category page

  • K923397Single Dose Gas InjectorEscalon Medical Trek · 1992
  • K875075RT-200 Computer InterfaceTimeter Instrument Corp. · 1988
  • K850029Utah Pressure Transducer Calibrator Tru-CalUtah Medical Products, Inc. · 1985
  • K801257Needle Counter-Sure Count/30 CT. Magn.Kleen Test Products · 1980
  • K801258Needle Counter-Sure Count/10 CountKleen Test Products · 1980

https://510kreport.com/device/K822746 · printed Nov 4, 2026

Cite this page

510(k) Report. “K822746: RT-200 Calibration Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K822746

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