North American Sterilization & Packaging Co.: FDA clearances and approvals
North American Sterilization & Packaging Co. has 16 FDA 510(k) clearances (first 1989, latest 1997), across 13 product codes in 5 review panels. Median 510(k) review time: 146 days.
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 |
|---|---|---|---|
| FAS | Electrode, Electrosurgical, Active, Urological | 2 | 2 |
| KOQ | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) | 2 | 2 |
| LDQ | 2 | 2 | |
| BTQ | Airway, Nasopharyngeal | 1 | 1 |
| FAD | Stent, Ureteral | 1 | 1 |
| FPD | Tube, Feeding | 1 | 1 |
| GAZ | Tubing, Noninvasive | 1 | 1 |
| HMW | Drape, Microscope, Ophthalmic | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
| KNY | Accessories, Catheter, G-U | 1 | 1 |
Plus 3 more product codes.
Review panels
- Gastroenterology and Urology (6)
- General and Plastic Surgery (3)
- Dental (2)
- General Hospital (2)
- Anesthesiology (1)
Most recent North American Sterilization & Packaging Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964231 | NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) | KMF | 1997-03-10 | 138 |
| K963753 | NASP TRANSPARENT DRESSING | MGP | 1996-11-29 | 72 |
| K962352 | HYDROGEL SKIN DRESSING | NAE | 1996-08-02 | 45 |
| K925593 | NORTEC STERILE WATER FOR DEVICE IRRIGATION | LDQ | 1993-12-03 | 393 |
| K925588 | NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI | LDQ | 1993-12-03 | 393 |
| K925161 | NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO | KNY | 1993-07-21 | 281 |
| K911865 | NORTEC CONNECTING TUBE SET | GAZ | 1991-11-01 | 189 |
| K911784 | NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY | BTQ | 1991-09-23 | 154 |
| K910691 | NORTEC URETERAL STENT | FAD | 1991-08-15 | 177 |
| K903162 | FLEXIBLE ENDOSCOPIC ELECTRODES | FAS | 1990-12-18 | 153 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named North American Sterilization & Packaging Co..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does North American Sterilization & Packaging Co. have?
North American Sterilization & Packaging Co. has 16 FDA 510(k) clearances (first 1989, latest 1997), across 13 product codes in 5 review panels.
How long does FDA take to clear North American Sterilization & Packaging Co.'s 510(k)s?
The median time from FDA receipt to decision across North American Sterilization & Packaging Co.'s cleared 510(k)s is 146 days.
What devices does North American Sterilization & Packaging Co. make?
Its most frequent FDA product codes are FAS (Electrode, Electrosurgical, Active, Urological, 2); KOQ (Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&), 2); LDQ (device, 2).
Has North American Sterilization & Packaging Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching North American Sterilization & Packaging Co. Related entities may recall under other names.
Next steps
- See all 16 North American Sterilization & Packaging Co. clearances with predicates and recalls
- Run predicate analysis for product code FAS, North American Sterilization & Packaging Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.