Orion Life Systems, Inc.: FDA clearances and approvals
Orion Life Systems, Inc. has 33 FDA 510(k) clearances (first 1990, latest 1995), across 18 product codes in 5 review panels. Median 510(k) review time: 108 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOL | Catheter And Tip, Suction | 8 | 8 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 5 | 5 |
| BSY | Catheters, Suction, Tracheobronchial | 2 | 2 |
| EYN | Tray, Irrigation, Sterile | 2 | 2 |
| FCE | Enema Kit | 2 | 2 |
| KNY | Accessories, Catheter, G-U | 2 | 2 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| HED | Douche Apparatus, Vaginal, Therapeutic | 1 | 1 |
Plus 8 more product codes.
Review panels
- Gastroenterology and Urology (13)
- General Hospital (10)
- General and Plastic Surgery (5)
- Anesthesiology (3)
- Obstetrics and Gynecology (1)
Most recent Orion Life Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943835 | PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID | KNY | 1995-01-24 | 172 |
| K943836 | PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER | JOL | 1994-11-21 | 108 |
| K943834 | STERILE .9% SODIUM CHLORIDE SOLUTION | JOL | 1994-11-21 | 108 |
| K943832 | STERILE .9% SODIUM CHLORIDE FOR IRRATION | JOL | 1994-11-21 | 108 |
| K943831 | PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER | JOL | 1994-11-21 | 108 |
| K943830 | PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION | JOL | 1994-11-21 | 108 |
| K943829 | PRE-FILLED SYSRINGE W/STERILE WATER | JOL | 1994-11-21 | 108 |
| K943828 | STERILE WATER FOR IRRIGATION | JOL | 1994-11-21 | 108 |
| K943833 | STERILE WATER FOR IRRATION | JOL | 1994-11-01 | 88 |
| K923168 | DUAL PORT ENTERAL Y-ADAPTOR | KNT | 1994-06-17 | 718 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orion Life Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Orion Life Systems, Inc. have?
Orion Life Systems, Inc. has 33 FDA 510(k) clearances (first 1990, latest 1995), across 18 product codes in 5 review panels.
How long does FDA take to clear Orion Life Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Orion Life Systems, Inc.'s cleared 510(k)s is 108 days.
What devices does Orion Life Systems, Inc. make?
Its most frequent FDA product codes are JOL (Catheter And Tip, Suction, 8); FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), 5); BSY (Catheters, Suction, Tracheobronchial, 2).
Has Orion Life Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Orion Life Systems, Inc. Related entities may recall under other names.
Next steps
- See all 33 Orion Life Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOL, Orion Life Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.