Medcare Custom Packaging, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Medcare Custom Packaging, Inc.” (first 1990, latest 1996), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 99 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| JOL | Catheter And Tip, Suction | 2 | 2 |
| LRO | General Surgery Tray | 2 | 2 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| HHT | Spatula, Cervical, Cytological | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
- General Hospital (7)
- General and Plastic Surgery (2)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Medcare Custom Packaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954869 | MEDCARE YANKAUER SUCTION DEVICE | GCX | 1996-01-19 | 87 |
| K954442 | STERILE ISOTONIC SALINE & STERILE WATER | JOL | 1995-12-21 | 87 |
| K952759 | TOWEL PACK | KKX | 1995-09-29 | 105 |
| K950390 | URETHRAL CATHETERIZATION TRAY | FCM | 1995-05-30 | 118 |
| K943661 | STERILE PHYSIOLOGICAL SALINE/STERILE WATER | JOL | 1995-04-10 | 256 |
| K951149 | SINGLE USE INSTRUMENT TRAY | LRO | 1995-04-06 | 24 |
| K934732 | PELVIC EXAM TRAY | HHT | 1994-12-30 | 457 |
| K942000 | BURN DRESSING TRAY | FRG | 1994-05-20 | 25 |
| K936261 | CATHETER INSERTION TRAY | FMI | 1994-03-10 | 80 |
| K922179 | CATHETER INSERTION TRAY | FMI | 1993-07-02 | 420 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medcare Custom Packaging, Inc..
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.
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.
- Medcare Products (20 510(k)s)
- Medcare Medical Group, Inc. (8 510(k)s)
- Medcare Disp Products, Inc. (6 510(k)s)
- Medcare Flaga (4 510(k)s)
- Medcare Manufacturing, Inc. (1 510(k)s)
- Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medcare Custom Packaging, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Medcare Custom Packaging, Inc.” (first 1990, latest 1996), across 8 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 Medcare Custom Packaging, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medcare Custom Packaging, Inc. is 99 days.
Which FDA product codes appear under Medcare Custom Packaging, Inc.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 2); JOL (Catheter And Tip, Suction, 2); LRO (General Surgery Tray, 2).
Next steps
- See all 11 Medcare Custom Packaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Medcare Custom Packaging, 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 (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.