FDA product code JOL: Catheter And Tip, Suction
JOL is the FDA product code for catheter and tip, suction. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel. FDA has cleared 84 510(k) submissions under JOL, from 61 different applicants. The average 510(k) review took 126 days (median 87). FDA has posted 16 recalls for JOL devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter And Tip, Suction |
| Device class | Class II |
| Regulation | 21 CFR 880.6740 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JOL clearance
Top JOL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orion Life Systems, Inc. | 8 | 1994-11-21 |
| Baxter Healthcare Corp | 4 | 2005-08-12 |
| Sherwood Medical Co. | 4 | 1995-12-15 |
| Primary Care Solutions, Inc. | 2 | 2001-07-12 |
| Welcon, Inc. | 2 | 2001-05-01 |
56 more applicants have JOL clearances. See the full list in Caduvo.
Most recent JOL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051370 | Baxter Healthcare Corp | STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 | 2005-08-12 | 78 |
| K000266 | Primary Care Solutions, Inc. | PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION | 2001-07-12 | 531 |
| K000265 | Primary Care Solutions, Inc. | PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION | 2001-07-12 | 531 |
| K003402 | Welcon, Inc. | WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION | 2001-05-01 | 181 |
| K994321 | Automatic Liquid Packaging, Inc. | STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP | 2000-10-25 | 308 |
Recalls for JOL devices
16 product recalls in 15 recall events; 8 initiated in the last five years and 9 still open. Most recent: 2026-03-05.
| Year | Recalls |
|---|---|
| 2019 | 4 |
| 2023 | 3 |
| 2024 | 1 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code JOL?
JOL is the FDA product code for catheter and tip, suction. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel.
What device class is JOL?
Class II, regulation 21 CFR 880.6740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JOL?
Across 84 cleared submissions the average was 126 days from receipt to decision (median 87).
Which companies have the most JOL clearances?
Orion Life Systems, Inc. (8); Baxter Healthcare Corp (4); Sherwood Medical Co. (4); Primary Care Solutions, Inc. (2); Welcon, Inc. (2).
Have JOL devices been recalled?
Yes: 16 product recalls across 15 recall events; the most recent began 2026-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code JOL
- Run a recall and safety report across every JOL manufacturer
- Watch product code JOL 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times