510(k) · Cleared
Recalled · 2010Stryker Infravision Esophageal Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Cleared on Jun 4, 1999 as substantially equivalent to K960173 (Gabriel Medical, Inc., 1996) and 3 other predicates after a 263-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jun 4, 1999
- Review
- 263 days
- Class
- Class II
- Product code
- FAT
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 2 generations to K934084 (1993). 6 ancestors in all, the oldest K810156 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK934084 Bioenterics Endolumina Illuminating BougieBioenterics Corp. · 1993
- 1 generation backK960173 Infra Vision Bougie Kit, Infra Vision Esophageal KitGabriel Medical, Inc. · 1996
- This deviceK983220 Stryker Infravision Esophageal KitStryker Endoscopy · 1999
- Descendant · cites it directly · 0 of its ownK130906 Endoflip CatheterCrospon, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130906Endoflip CatheterCrospon, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934084 | Bioenterics Endolumina Illuminating Bougie | Bioenterics Corp. | 1993 | — |
| −1 | K960173 | Infra Vision Bougie Kit, Infra Vision Esophageal Kit | Gabriel Medical, Inc. | 1996 | — |
| 0 (this device) | K983220 | Stryker Infravision Esophageal Kit | Stryker Endoscopy | 1999 | — |
| +1 | K130906 | Endoflip Catheter | Crospon, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FAT? 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
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960173 | Infra Vision Bougie Kit, Infra Vision Esophageal KitSummary page 1…ses. The Stryker InfraVision™ Esophageal Kit is equivalent in safety and effectivencss to a variety of devices currently marketed (Gabriel InfraVision™ Esophageal Kit - K960173; Bard Balloon Dilatation System - K863437, Sherwood Argyle Salem Sump Tube - K810156; BioEnterics EndoLumina Illuminated Bougie… | 1996 |
| * | K863437 | Bard Balloon Dilatation SystemSummary page 1…Kit is equivalent in safety and effectivencss to a variety of devices currently marketed (Gabriel InfraVision™ Esophageal Kit - K960173; Bard Balloon Dilatation System - K863437, Sherwood Argyle Salem Sump Tube - K810156; BioEnterics EndoLumina Illuminated Bougie - K934048) which are used in the applicati… | 1986 |
| * | K810156 | Argyle Salem Sump TubeSummary page 1…s to a variety of devices currently marketed (Gabriel InfraVision™ Esophageal Kit - K960173; Bard Balloon Dilatation System - K863437, Sherwood Argyle Salem Sump Tube - K810156; BioEnterics EndoLumina Illuminated Bougie - K934048) which are used in the applications noted above. This device does not raise… | 1981 |
| * | K934084 | Bioenterics Endolumina Illuminating Bougie Our OCR of the scanned summary read K934048, FDA’s number for GH Gloves (Powder Free) (Grafik Hersteller Sdn Bhd). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “BioEnterics EndoLumina Illuminated Bougie”. | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130906 | Endoflip Catheter | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2010 | Not classified | Z-1002-2011 | Device Design | The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body. |
| Aug 20, 2009 | Not classified | Z-0830-2011 | Device Design | The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K130906 (Crospon, Ltd., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FAT devicesFAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAT
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FAT
Too few FAT 510(k)s in any year since 2007 to give a median.
Recalls per year · FAT
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAT
2in 2025
MAUDE reports naming product code FAT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 1 | 5 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stryker InfraVision™ Esophageal Kit is an esophageal transillumination dilation device with a reusable illumination source, and a combined single use disposable fiberoptic light guide, nasogastric tube and balloon dilation system. The Stryker InfraVision™ Esophageal Kit is intended w0 wansilluminate and dilate the esaphagus during, the fundoplication procedure as well as other thoracoscopic, laparoscopic, or open surgical procedures. Transillumination is intended to help the surgeon identify organs and placement of medical devices within body tissue.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983220 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983220: Stryker Infravision Esophageal Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983220
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026