FDA product code FJS: Catheter, Peritoneal, Long-Term Indwelling
FJS is the FDA product code for catheter, peritoneal, long-term indwelling. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 48 510(k) submissions under FJS, 1 in the last five years, from 21 different applicants. The average 510(k) review took 139 days (median 98). FDA has posted 8 recalls for FJS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Peritoneal, Long-Term Indwelling |
| Device class | Class II |
| Regulation | 21 CFR 876.5630 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for FJS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 154 |
| 2022 | 1 | 60 |
Top FJS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quinton, Inc. | 8 | 1989-03-27 |
| Accurate Surgical Instruments Co. | 7 | 1995-12-15 |
| Medigroup, Inc. | 5 | 2012-05-21 |
| Janin Group, Inc. | 4 | 2002-02-04 |
| Sil-Med Corp. | 3 | 1997-07-18 |
16 more applicants have FJS clearances. See the full list in Caduvo.
Most recent FJS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213602 | Covidien, LLC | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit | 2022-01-14 | 60 |
| K180485 | Covidien, LLC | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender | 2018-07-27 | 154 |
| K130441 | Medionics International, Inc. | FALLER STYLET | 2013-04-19 | 57 |
| K121383 | Medical Components, Inc. | PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) | 2012-09-05 | 120 |
| K120130 | Medigroup, Inc. | FALLER TROCAR | 2012-05-21 | 125 |
Recalls for FJS devices
8 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-02-15.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code FJS?
FJS is the FDA product code for catheter, peritoneal, long-term indwelling. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel.
What device class is FJS?
Class II, regulation 21 CFR 876.5630. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJS?
Across 48 cleared submissions the average was 139 days from receipt to decision (median 98).
Which companies have the most FJS clearances?
Quinton, Inc. (8); Accurate Surgical Instruments Co. (7); Medigroup, Inc. (5); Janin Group, Inc. (4); Sil-Med Corp. (3).
Have FJS devices been recalled?
Yes: 8 product recalls across 5 recall events; the most recent began 2023-02-15.
Next steps
- Run an FDA pathway report with predicate devices for product code FJS
- Run a recall and safety report across every FJS manufacturer
- Watch product code FJS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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