Packaging Technologies, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Packaging Technologies, Inc.” (first 1983, latest 1988), across 13 product codes in 5 review panels. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 1 | 1 |
| FMC | Patient Examination Glove | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
| KME | Bedding, Disposable, Medical | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
Plus 3 more product codes.
Review panels
- General Hospital (6)
- General and Plastic Surgery (4)
- Cardiovascular (1)
- Dental (1)
- Gastroenterology and Urology (1)
Most recent Packaging Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K881756 | STERILE SURGEONS GLOVES | KGO | 1988-06-01 | 37 |
| K863326 | BONE MARROW TRAY | GAA | 1986-09-16 | 20 |
| K861041 | ENHANCE | LYC | 1986-05-30 | 73 |
| K850544 | SHAVE PREP TRAY | KME | 1985-03-12 | 28 |
| K850438 | RENAL BIOPSY TRAY | KNW | 1985-02-26 | 21 |
| K844613 | GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR | FSM | 1985-01-10 | 44 |
| K844614 | IV START KIT | LRS | 1984-12-19 | 22 |
| K844611 | SINGLE BASIN SET | FRG | 1984-12-19 | 22 |
| K844612 | ACUTE HEMODIALYSIS TRAYS | KNZ | 1984-12-17 | 20 |
| K834074 | PERCUTANEOUS SHEATH INTRODUCER TRAY | DYB | 1984-03-19 | 115 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Packaging Technologies, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Packaging Technologies, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Packaging Technologies, Inc.” (first 1983, latest 1988), across 13 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 Packaging Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Packaging Technologies, Inc. is 37 days.
Which FDA product codes appear under Packaging Technologies, Inc.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 1); FMC (Patient Examination Glove, 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1).
Next steps
- See all 13 Packaging Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Packaging Technologies, 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.