510(k) Report

510(k) · Cleared

Cleared

Bioenterics Endolumina Illuminating Bougie

K934084510(k) TraditionalCleared Dec 16, 1993118-day reviewClass I21 CFR 886.1810

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

Bioenterics Corp. · HMJ Screen, Tangent, Projection, Battery-Powered

Cleared on Dec 16, 1993 after a 118-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Dec 16, 1993
Review
118 days
Class
Class I
Product code
HMJ
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1999: 1 descendant cleared2013: 1 descendant cleared1990200020102020
  1. This deviceK934084 Bioenterics Endolumina Illuminating BougieBioenterics Corp. · 1993
  2. Descendant · cites it directly · 2 of its ownK960173 Infra Vision Bougie Kit, Infra Vision Esophageal KitGabriel Medical, Inc. · 1996
  3. Descendant · cites it directly · 1 of its ownK983220 Stryker Infravision Esophageal KitStryker Endoscopy · 1999 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK130906 Endoflip CatheterCrospon, Ltd. · 2013

Most influential descendants

Showing 3 of 3 · See all
  • K960173Infra Vision Bougie Kit, Infra Vision Esophageal KitGabriel Medical, Inc. · 1996 · cites it directly2descendants
  • K983220Stryker Infravision Esophageal KitStryker Endoscopy · 1999 · cites it directly1descendant
  • K130906Endoflip CatheterCrospon, Ltd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934084Bioenterics Endolumina Illuminating BougieBioenterics Corp.1993—
+1K960173Infra Vision Bougie Kit, Infra Vision Esophageal KitGabriel Medical, Inc.1996—
+1K983220Stryker Infravision Esophageal KitStryker Endoscopy19992
+2K130906Endoflip CatheterCrospon, Ltd.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
201310
FIG. 1 — Lineage of K934084, 1993–2013Source: FDA 510(k) summaries, read by 510(k) Report · 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 HMJ? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960173Infra Vision Bougie Kit, Infra Vision Esophageal KitGabriel Medical, Inc.19962
K983220Stryker Infravision Esophageal KitStryker Endoscopy19991

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, K960173 (Gabriel Medical, Inc., 1996) has gone furthest, with 2 descendants of its own.

How does its category compare?

All HMJ devices

HMJ Screen, Tangent, Projection, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HMJ

FDA has decided no HMJ device since 2007.

Median 510(k) review, days · HMJ

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

Recalls per year · HMJ

No recall names HMJ since 2007.

Adverse event reports per year · HMJ

No MAUDE report names HMJ 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—

More from Bioenterics Corp.

4 FDA decisions under this applicant name. See the company

  • K002838Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
  • K964561Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR E-4020, Endolumina II Detachable…Bioenterics Corp. · 1997
  • K924753Bioentrics Endolumina Illuminated BougieBioenterics Corp. · 1992

Recent decisions in HMJ

The HMJ category page

  • K924753Bioentrics Endolumina Illuminated BougieBioenterics Corp. · 1992

https://510kreport.com/device/K934084 · printed Nov 5, 2026

Cite this page

510(k) Report. “K934084: Bioenterics Endolumina Illuminating Bougie.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K934084

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026