510(k) · Cleared
ClearedPilling Esophageal Bougies
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Cleared on Jun 16, 2014 as substantially equivalent to K972119 (Medovations, Inc., 1998) after a 216-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jun 16, 2014
- Review
- 216 days
- Class
- Class II
- Product code
- FAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972119 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK972119 Maloney Bouge (1210-XX)/Hurst Bougie (1212-XX)Medovations, Inc. · 1998
- This deviceK133439 Pilling Esophageal BougiesTeleflexmedical, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972119 | Maloney Bouge (1210-XX)/Hurst Bougie (1212-XX) | Medovations, Inc. | 1998 | — |
| 0 (this device) | K133439 | Pilling Esophageal Bougies | Teleflexmedical, Inc. | 2014 | — |
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? (1)
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 |
|---|---|---|---|
| * | K972119 | Maloney Bouge (1210-XX)/Hurst Bougie (1212-XX)Summary page 2…ices: IPredicate Device Manufacturer 510(k) No. Date Cleared Medovations® M-FlexTM Medovations, Inc. K9721 19 02/02/1998 Esophageal Bougies 1. Comparison to Predicate Devices The proposed Pilling® Esophageal Bougies have the… | 1998 |
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.
What does this lineage say?
- Its one ancestor has no recall.
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. 2014, this device’s year, is highlighted.
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 Pilling® Esophageal Bougies are indicated for the dilation of upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures and temporary ease of esophageal carcinoma.
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/K133439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133439: Pilling Esophageal Bougies.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133439
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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