Apothecary Products, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Apothecary Products, Inc.” (first 1984, latest 2014), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 136 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 | 1 | 141 |
| 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 |
|---|---|---|---|
| EWD | Protector, Hearing (Insert) | 1 | 1 |
| LRX | Case, Contact Lens | 1 | 1 |
| LXQ | Cup, Eye | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
| MVV | Device, Acupressure | 1 | 1 |
| NXB | Dispenser, Solid Medication | 1 | 1 |
Review panels
- General Hospital (2)
- Ophthalmic (2)
- Ear, Nose and Throat (1)
- Neurology (1)
Most recent Apothecary Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140409 | FLENTS PLASTIC EYE WASH CUP | LXQ | 2014-07-09 | 141 |
| K111856 | SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE | LRX | 2011-07-14 | 15 |
| K041766 | EZY-TRAVEL WRISTBAND | MVV | 2004-11-26 | 149 |
| K020296 | ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 | EWD | 2002-06-25 | 148 |
| K892242 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-05-12 | 37 |
| K833311 | NITROGLYCERINE CONTAINER | NXB | 1984-02-04 | 131 |
Recalls
2 product recalls in 1 recall events; 2 initiated in the last five years. Most recent: 2023-03-30.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Apothecary Products, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Apothecary Products, Inc.” (first 1984, latest 2014), across 6 product codes in 4 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 Apothecary Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apothecary Products, Inc. is 136 days.
Which FDA product codes appear under Apothecary Products, Inc.?
The most frequent FDA product codes under this applicant name are EWD (Protector, Hearing (Insert), 1); LRX (Case, Contact Lens, 1); LXQ (Cup, Eye, 1).
Next steps
- See all 6 Apothecary Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EWD, Apothecary Products, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.