510(k) Report

510(k) · Cleared

Cleared

Respiratory Flow Module

K833265510(k) TraditionalCleared Nov 28, 198368-day reviewClass II21 CFR 868.2550

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

Thoratec Laboratories Corp. · JAX Pneumotachometer

Cleared on Nov 28, 1983 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 28, 1983
Review
68 days
Class
Class II
Product code
JAX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K833265Source: FDA 510(k) database · 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 JAX? 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?

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 JAX devices

JAX Pneumotachometer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAX

FDA has decided no JAX device since 2007.

Median 510(k) review, days · JAX

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

Recalls per year · JAX

No recall names JAX since 2007.

Adverse event reports per year · JAX

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code JAX, 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—00
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 Thoratec Laboratories Corp.

69 FDA decisions under this applicant name. See the company

  • P870072/S062Thoratec (R) Ventricular Assist Device (Vad) SystemThoratec Laboratories Corp. · 2016
  • P870072/S061Thoratec Ventricular Assist Device SystemThoratec Laboratories Corp. · 2016
  • P870072/S060Thoratec Ventricular Assist Device SystemThoratec Laboratories Corp. · 2015
  • P870072/S059Thoratec Ventricular Assist DeviceThoratec Laboratories Corp. · 2014
  • P870072/S058Thoratec Ventricular Assist Device (Vad)Thoratec Laboratories Corp. · 2013

Recent decisions in JAX

The JAX category page

  • K990962Flosense, Model 29-8010Sdi Diagnostics, Inc. · 2000
  • K921178Pti-a, Pti-P, Pti-N Disposable PneumotachsMedical Associated Services, Inc. · 1992
  • K884464Spirometrics Model 2200 SM200 Flow SensorSpirometrics, Inc. · 1989
  • K853085Pax MeterPeace Medical, Inc. · 1985
  • K812825Flo-Cor IBiotrine Corp. · 1981

https://510kreport.com/device/K833265 · printed Nov 4, 2026

Cite this page

510(k) Report. “K833265: Respiratory Flow Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833265

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
  • Page last updated Nov 3, 2026