Ortho Pharmaceutical Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Ortho Pharmaceutical Corp.” (first 1979, latest 1996), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| HIS | Condom | 2 | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 2 |
| FRN | Pump, Infusion | 1 | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 | 1 |
| JSJ | Culture Media, Selective And Non-Differential | 1 | 1 |
| KMJ | Lubricant, Patient | 1 | 1 |
| LXK | Scrapper, Skin Specimen | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- General Hospital (2)
- Obstetrics and Gynecology (2)
- Microbiology (1)
- General and Plastic Surgery (1)
Most recent Ortho Pharmaceutical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955648 | K-Y PERSONAL LUBRICANT | HIS | 1996-06-21 | 192 |
| K934516 | ADVANCE PREGNANCY TEST MODIFICATION | LCX | 1994-02-24 | 160 |
| K914990 | ADVANCE(R) PREGNANCY TEST | LCX | 1991-12-23 | 46 |
| K893488 | PULSATILE PUMP FOR GONADORELIN ACETATE | FRN | 1989-10-31 | 180 |
| K881151 | MICROSCRAPE | LXK | 1988-04-06 | 20 |
| K810581 | FACT* HOME PREGNANCY TEST | JHJ | 1981-03-17 | 14 |
| K800754 | NICKERSON'S MED. SELECTIVE CULTURE MEDIU | JSJ | 1980-04-29 | 25 |
| K792634 | CONCEPTROL/THIN PROPHYLACTICS | HIS | 1980-01-16 | 28 |
| K790087 | LUBRICANT, OTRHO PERSONAL | KMJ | 1979-02-01 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Ortho Pharmaceutical Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ortho Pharmaceutical Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ortho-Clinical Diagnostics, Inc. (142 510(k)s)
- Ortho Diagnostic Systems, Inc. (126 510(k)s)
- Ortho Development Corp. (64 510(k)s)
- Ortho Diagnostics, Inc. (24 510(k)s)
- Ortho Tec, LLC (22 510(k)s)
- Ortho Source (9 510(k)s)
- Ortho Organizers, Inc. (8 510(k)s)
- Ortho Kinetics Corp. (7 510(k)s)
- Ortho Instruments (6 510(k)s)
- Ortho Kinematics, Inc. (6 510(k)s)
- Ortho Solutions Limited (6 510(k)s)
- Ortho Solutions UK , Ltd. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ortho Pharmaceutical Corp.?
FDA lists 9 510(k) clearances under the applicant name “Ortho Pharmaceutical Corp.” (first 1979, latest 1996), across 7 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ortho Pharmaceutical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ortho Pharmaceutical Corp. is 28 days.
Which FDA product codes appear under Ortho Pharmaceutical Corp.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 2); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 2); FRN (Pump, Infusion, 1).
Next steps
- See all 9 Ortho Pharmaceutical Corp. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Ortho Pharmaceutical Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.