Healthscan Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Healthscan Products, Inc.” (first 1993, latest 1996), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | 3 | 3 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Healthscan Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962924 | PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM | BZH | 1996-10-25 | 88 |
| K962929 | PERSONAL BEST II | BZH | 1996-10-24 | 87 |
| K962822 | OPTICHAMBER | CAF | 1996-10-17 | 90 |
| K961077 | PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE | BWF | 1996-07-15 | 119 |
| K933889 | PERSONAL BEST LOW RANGE | BZH | 1993-09-09 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Healthscan 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Healthscan Products, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Healthscan Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Healthscan Products, Inc.” (first 1993, latest 1996), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Healthscan Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Healthscan Products, Inc. is 88 days.
Which FDA product codes appear under Healthscan Products, Inc.?
The most frequent FDA product codes under this applicant name are BZH (Meter, Peak Flow, Spirometry, 3); BWF (Spirometer, Therapeutic (Incentive), 1); CAF (Nebulizer (Direct Patient Interface), 1).
Next steps
- See all 5 Healthscan Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZH, Healthscan 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, 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.