510(k) · Cleared
ClearedPatCom Single-Use Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H&A Mui Enterprises, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Feb 21, 2020 as substantially equivalent to K100081 (United States Endoscopy Group, Inc., 2010) after a 148-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Feb 21, 2020
- Review
- 148 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K993704 (2000). 14 ancestors in all, the oldest K853585 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 5 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 4 generations backK052084 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005
- 3 generations backK060235 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2006
- 2 generations backK080050 Spirus Medical Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2008
- 1 generation backK100081 Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc. · 2010
- This deviceK192691 PatCom Single-Use IntroducerH&A Mui Enterprises, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −5 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −4 | K052084 | Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2005 | — |
| −3 | K060235 | Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2006 | — |
| −2 | K080050 | Spirus Medical Endo-Ease Endoscopic Overtube | Spirus Medical, Inc. | 2008 | — |
| −1 | K100081 | Enteroscopy Overtube, Model 00712140 | United States Endoscopy Group, Inc. | 2010 | — |
| 0 (this device) | K192691 | PatCom Single-Use Introducer | H&A Mui Enterprises, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 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 FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 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 |
|---|---|---|---|
| * | K100081 | Enteroscopy Overtube, Model 00712140Summary page 5…laiming equivalence to the following predicate device: Product Name 510(k) Number Manufacturer Enteroscopy Overtube K100081 United States Endoscopy Group The PatCom Single-Use Introducers are similar to the overtubes manufactured by… | 2010 |
| † | K823701 | Motility Catheters | 1983 |
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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K100081.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | 1 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
The Single-Use Introducer is used for patient esophageal intubation to guide the catheters and tubes via the nasal or oral cavity. It is to be used in conjunction with endoscopes to allow visualization of the placement process. The Single-Use Introducer is to be used in a hospital or clinical setting and under the supervision of a qualified healthcare professional who has received professional training in using the equipment.
The Single-Use Introducer is provided non-sterile, and is intended to be non-reusable.
The Single-Use Introducer is for transient use (under 24 hrs), and will come in direct contact with the patient’s mucosal lining.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192691 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192691: PatCom Single-Use Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192691
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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