Specialty Packaging Producs, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Specialty Packaging Producs, Inc.” (first 1991, latest 1992), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| BYG | Mask, Oxygen | 3 | 3 |
| BYX | Tubing, Pressure And Accessories | 1 | 1 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
| KGB | Mask, Oxygen, Non-Rebreathing | 1 | 1 |
Review panels
- Anesthesiology (10)
- General Hospital (1)
Most recent Specialty Packaging Producs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922492 | SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER | CAH | 1992-08-24 | 89 |
| K913163 | NON REBREATHING VALVE | CBP | 1992-02-03 | 201 |
| K913422 | OXYGEN TUBING, 81503 | BYX | 1992-01-30 | 183 |
| K913216 | TRACH T ADAPTER | BZA | 1992-01-15 | 180 |
| K913164 | NON REBREATHING MASK | KGB | 1992-01-15 | 182 |
| K913421 | NASAL OXYGEN CANNULA, 81585, 81587 & 81589 | CAT | 1991-10-18 | 79 |
| K913383 | OXYGEN MASKS 81420, 81421, 81471 & 81461 | BYG | 1991-10-18 | 81 |
| K913275 | VENTURI OXYGEN MASK | BYG | 1991-10-10 | 79 |
| K913220 | AEROSOL MASKS, 81426, 81476, 81490 & 81492 | CAF | 1991-10-10 | 83 |
| K913455 | OXYGEN MASKS 82400 & 82405 | BYG | 1991-10-02 | 61 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Specialty Packaging Producs, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Specialty Packaging Producs, Inc. (a text match, not an official crosswalk):
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.
- Specialty Surgical Products, Inc. (13 510(k)s)
- Specialty Ultravision, Inc. (12 510(k)s)
- Specialty Medical Products Co. (4 510(k)s)
- Specialty Appliance Works, Inc. (3 510(k)s)
- Specialty Medical Industries, Inc. (3 510(k)s)
- Specialty Fibres and Materials, Ltd. (2 510(k)s)
- Specialty Health Products, Inc. (2 510(k)s)
- Specialty Spine Products, LLC (2 510(k)s)
- Specialty Water Technologies, Inc. (2 510(k)s)
- Specialty Dialysis Services (1 510(k)s)
- Specialty Drives Technologies, Inc. (1 510(k)s)
- Specialty Engineering, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Specialty Packaging Producs, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Specialty Packaging Producs, Inc.” (first 1991, latest 1992), across 9 product codes in 2 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 Specialty Packaging Producs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Specialty Packaging Producs, Inc. is 83 days.
Which FDA product codes appear under Specialty Packaging Producs, Inc.?
The most frequent FDA product codes under this applicant name are BYG (Mask, Oxygen, 3); BYX (Tubing, Pressure And Accessories, 1); BZA (Connector, Airway (Extension), 1).
Next steps
- See all 11 Specialty Packaging Producs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BYG, Specialty Packaging Producs, 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.