510(k) · Cleared
ClearedPerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adapta Medical, Inc. · EZD Catheter, Straight
Cleared on Aug 16, 2016 as substantially equivalent to K103043 (Adapta Medical, Inc., 2011) and 1 other predicate after an 83-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Aug 16, 2016
- Review
- 83 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003874 (2001). 12 ancestors in all, the oldest K896750 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK003874 CBC-4K Hematology ControlR&D Systems, Inc. · 2001
- 3 generations backK052440 Mentor Self-Cath Hydrogel Intermittent CatheterMentor Corporation · 2005
- 2 generations backK071496 Icath, SterilesureColorado Catheter Company, Inc. · 2007
- 1 generation backK103043 Colorado Catheter Sterilesure - New Name Perfic CathAdapta Medical, Inc. · 2011
- This deviceK161445 PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC…Adapta Medical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003874 | CBC-4K Hematology Control | R&D Systems, Inc. | 2001 | — |
| −3 | K052440 | Mentor Self-Cath Hydrogel Intermittent Catheter | Mentor Corporation | 2005 | — |
| −2 | K071496 | Icath, Sterilesure | Colorado Catheter Company, Inc. | 2007 | — |
| −1 | K103043 | Colorado Catheter Sterilesure - New Name Perfic Cath | Adapta Medical, Inc. | 2011 | — |
| 0 (this device) | K161445 | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C | Adapta Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 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 EZD? 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 EZD device
- #1 K241210 Luja Coudescore 16.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K103043 | Colorado Catheter Sterilesure - New Name Perfic CathSummary page 4…ic Catheter and Accessories Regulation: 21 CFR §876.5130 Regulatory Class: Class II Product Code: EZD Predicate Device(s): Primary - Adapta Medical: PerfIC Cath™ (K103043) Secondary “Reference” Predicate – Hangzhou Bever Medical Device Co., Ltd.: Bever Medical Intermittent C… | 2011 |
| * | K111405 | Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip…Summary page 4…Medical: PerfIC Cath™ (K103043) Secondary “Reference” Predicate – Hangzhou Bever Medical Device Co., Ltd.: Bever Medical Intermittent Catheters (K111405) Device Description: The PerfIC Cath™ is a single-use urinary catheter for intermittent use. The catheter is made of a simple p… | 2012 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 12 ancestors has a recall of any class.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · EZD
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EZD
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZD
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZD
288in 2025
MAUDE reports naming product code EZD, 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 | 4 | 121 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 4 | 116 | 1 | 4 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 4 | 110 | 0 | 18 |
| 2014 | 5 | 91 | 1 | 17 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 3 | 83 | 0 | 21 |
| 2017 | 2 | — | 0 | 120 |
| 2018 | 3 | 122 | 0 | 390 |
| 2019 | 0 | — | 0 | 466 |
| 2020 | 1 | — | 0 | 563 |
| 2021 | 0 | — | 0 | 994 |
| 2022 | 10 | 288 | 0 | 487 |
| 2023 | 6 | 214 | 0 | 553 |
| 2024 | 5 | 147 | 0 | 116 |
| 2025 | 6 | 130 | 0 | 288 |
| 2026 | 11 | 146 | 0 | — |
What is it indicated for?
The PerfIC Cath™ is intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161445: PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161445
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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