Health Products, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Health Products, Inc.” (first 1986, latest 1992), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 69 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | 4 | 4 |
| BZH | Meter, Peak Flow, Spirometry | 3 | 3 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 1 | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| INO | Chair, Positioning, Electric | 1 | 1 |
| IOQ | Bed, Flotation Therapy, Powered | 1 | 1 |
| KQX | Goniometer, Ac-Powered | 1 | 1 |
Review panels
- Anesthesiology (8)
- General Hospital (2)
- Physical Medicine (2)
- Neurology (1)
Most recent Health Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912866 | PEAK EXPIRATORY FLOW METER | BZH | 1992-08-13 | 412 |
| K912943 | THRESHOLD 2X INSPIRATORY MUSCLE TRAINER | BWF | 1992-01-30 | 209 |
| K911807 | METERED DOSE INHALER (MDI) SPACER | CAF | 1991-10-23 | 183 |
| K902292 | MODIFIED ASSESS(R) PEAK FLOW METER | BZH | 1990-08-10 | 80 |
| K896953 | MODIFIED ASSESS(R) PEAK FLOW METER | BZH | 1990-01-30 | 56 |
| K894353 | ORTHODERM CONVERTIBLE | IOQ | 1989-08-09 | 26 |
| K890426 | CONSUMMATE AIR THERAPY BED | FNL | 1989-04-05 | 69 |
| K874801 | ORTHODERM THERAPY BED | FNM | 1988-02-05 | 74 |
| K871742 | MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER | BWF | 1987-06-15 | 41 |
| K870514 | THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER | BWF | 1987-03-31 | 54 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Health 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 Health Products, 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.
- Health & Life Co., Ltd. (60 510(k)s)
- Health Line International Corporation (12 510(k)s)
- Health Hero Network, Inc. (8 510(k)s)
- Health Care Mfg., Inc. (7 510(k)s)
- Health Care Innovations, Inc. (5 510(k)s)
- Health Development Corp. (5 510(k)s)
- Health Images, Inc. (5 510(k)s)
- Health Beacons, Inc. (4 510(k)s)
- Health Improvement Assoc. (4 510(k)s)
- Health Scan, Inc. (4 510(k)s)
- Health Sense Intl., Inc. (4 510(k)s)
- Health Systems Intl., Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Health Products, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Health Products, Inc.” (first 1986, latest 1992), 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 Health Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Health Products, Inc. is 69 days.
Which FDA product codes appear under Health Products, Inc.?
The most frequent FDA product codes under this applicant name are BWF (Spirometer, Therapeutic (Incentive), 4); BZH (Meter, Peak Flow, Spirometry, 3); CAF (Nebulizer (Direct Patient Interface), 1).
Next steps
- See all 13 Health Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BWF, Health 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.