510(k) Report

510(k) · Cleared

Cleared

Tbi Trainer

K840837510(k) TraditionalCleared Mar 25, 1985395-day reviewClass I21 CFR 876.1500

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

Manico · FEJ Attachment, Binocular, For Endoscope

Cleared on Mar 25, 1985 after a 395-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 25, 1985
Review
395 days
Class
Class I
Product code
FEJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K840837Source: 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 FEJ? 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 FEJ devices

FEJ Attachment, Binocular, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FEJ

FDA has decided no FEJ device since 2007.

Median 510(k) review, days · FEJ

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

Recalls per year · FEJ

No recall names FEJ since 2007.

Adverse event reports per year · FEJ

No MAUDE report names FEJ since 2007.

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—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—

https://510kreport.com/device/K840837 · printed Nov 6, 2026

Cite this page

510(k) Report. “K840837: Tbi Trainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K840837

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