510(k) · Cleared
ClearedLehman Manometry Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · FFX System, Gastrointestinal Motility (Electrical)
Cleared on Jun 20, 2016 as substantially equivalent to K900058 (Wilson-Cook Medical, Inc., 1990) after a 145-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jun 20, 2016
- Review
- 145 days
- Class
- Class II
- Product code
- FFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900058 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK900058 Wilson-Cook Biliary Motility CatheterWilson-Cook Medical, Inc. · 1990
- This deviceK160170 Lehman Manometry CatheterWilson-Cook Medical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900058 | Wilson-Cook Biliary Motility Catheter | Wilson-Cook Medical, Inc. | 1990 | — |
| 0 (this device) | K160170 | Lehman Manometry Catheter | Wilson-Cook Medical, Inc. | 2016 | — |
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 FFX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FFX device
- #1 K262621 Rapid Barostat Bag (RBB) Pump and Catheter…score 12.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K900058 | Wilson-Cook Biliary Motility CatheterSummary page 4…cation Name: System, Gastrointestinal Motility (Electrical) 21 CFR 876.1725, FFX, Class II Predicate Device Wilson-Cook Biliary Motility Catheter, k900058, cleared July 27, 1990 Intended Use This device is used for motility studies in the common bile duct, pancreatic duct, Sphincte… | 1990 |
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.
- 1 other device also cites its predicate K900058.
How does its category compare?
All FFX devicesFFX System, Gastrointestinal Motility (Electrical): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FFX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FFX
123in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFX
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFX
32in 2025
MAUDE reports naming product code FFX, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 2 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 4 | 120 | 0 | 4 |
| 2013 | 1 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 3 | 145 | 0 | 15 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 1 | — | 0 | 17 |
| 2019 | 4 | 240 | 0 | 27 |
| 2020 | 1 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 26 |
| 2022 | 0 | — | 0 | 31 |
| 2023 | 3 | 123 | 0 | 51 |
| 2024 | 1 | — | 0 | 59 |
| 2025 | 1 | — | 0 | 32 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
This device is used for motility studies in the common bile duct, pancreatic duct, Sphincter of Oddi and duodenum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160170 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160170: Lehman Manometry Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160170
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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