Nice-Pak Products, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Nice-Pak Products, Inc.” (first 1978, latest 1998), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | 2 | 2 |
| GEC | Brush, Scrub, Operating-Room | 1 | 1 |
| HMP | Pad, Eye | 1 | 1 |
| IMD | Pack, Hot Or Cold, Disposable | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
| KHR | Absorber, Saliva, Paper | 1 | 1 |
| KMJ | Lubricant, Patient | 1 | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 | 1 |
Review panels
Most recent Nice-Pak Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974768 | PDI STERILE LUBRICATING JELLY | KMJ | 1998-01-16 | 25 |
| K840343 | PDI PREPMASTER WET PACK VAGINAL-X21477 | KGO | 1984-03-27 | 81 |
| K840342 | PDI PREPMASTER WET PACK PATIENT PREP KIT | FRG | 1984-03-27 | 81 |
| K840344 | PDI PREPMASTER WET PACK MINOR PROCEDURE | FRG | 1984-03-26 | 80 |
| K833549 | PDI SURGICAL SCRUB/BRUSH T150-70 | NAB | 1983-11-28 | 88 |
| K810337 | PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 | GEC | 1981-02-26 | 17 |
| K781539 | ISO-CARE KIT | HMP | 1978-11-03 | 56 |
| K780279 | ICE-PAK, PDI | IMD | 1978-04-10 | 48 |
| K780400 | DEN-Z-ORB | KHR | 1978-03-27 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Nice-Pak Products, 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.
- Nice Recovery Systems, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nice-Pak Products, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Nice-Pak Products, Inc.” (first 1978, latest 1998), 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 Nice-Pak Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nice-Pak Products, Inc. is 56 days.
Which FDA product codes appear under Nice-Pak Products, Inc.?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 2); GEC (Brush, Scrub, Operating-Room, 1); HMP (Pad, Eye, 1).
Next steps
- See all 9 Nice-Pak Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRG, Nice-Pak 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 (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.