Robert I. Chien & Assoc., Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Robert I. Chien & Assoc., Inc.” (first 1980, latest 1982), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 24 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 |
|---|---|---|---|
| HXD | Clamp | 2 | 2 |
| FLK | Thermometer, Clinical Mercury | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| GWZ | Percussor | 1 | 1 |
| HNF | Scissors, Ophthalmic | 1 | 1 |
Review panels
- General and Plastic Surgery (3)
- General Hospital (1)
- Neurology (1)
- Ophthalmic (1)
Most recent Robert I. Chien & Assoc., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K822151 | SURGICAL INSTRUMENTS REPRESENT. 4 CLASS | HNF | 1982-08-19 | 28 |
| K811632 | UNSTERILIZED LAPAROTOMY SPONGES (CHINA) | GDY | 1981-09-11 | 94 |
| K811631 | THERMOMETER (MADE IN CHINA) | FLK | 1981-07-20 | 41 |
| K810054 | RICA (DIAGNOSTIC INSTRUMENTS) | GWZ | 1981-01-28 | 16 |
| K801819 | SURGICAL INSTRUMENTS | HXD | 1980-08-20 | 20 |
| K801028 | RICA OR SMIC SURGICAL INSTRUMENTS | HXD | 1980-05-20 | 19 |
Recalls
openFDA lists no recalls under a recalling firm named Robert I. Chien & Assoc., 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.
- Robert Bosch Corp. (21 510(k)s)
- Robert R. Moore (5 510(k)s)
- Robert W. Bauer & Assoc., Inc. (3 510(k)s)
- Robert A James (2 510(k)s)
- Robert B. Scott Ocularists of Florida, Inc. (2 510(k)s)
- Robert R. Stevens (2 510(k)s)
- Robert Reid, Inc. (2 510(k)s)
- Robert Bosch Healthcare Systems, Inc. (1 510(k)s)
- Robert Busse & Co., Inc. (1 510(k)s)
- Robert C. Cameron (1 510(k)s)
- Robert C. Leif, Ph.D. (1 510(k)s)
- Robert E. Fenzl, M.D. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Robert I. Chien & Assoc., Inc.?
FDA lists 6 510(k) clearances under the applicant name “Robert I. Chien & Assoc., Inc.” (first 1980, latest 1982), across 5 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 Robert I. Chien & Assoc., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Robert I. Chien & Assoc., Inc. is 24 days.
Which FDA product codes appear under Robert I. Chien & Assoc., Inc.?
The most frequent FDA product codes under this applicant name are HXD (Clamp, 2); FLK (Thermometer, Clinical Mercury, 1); GDY (Gauze/Sponge, Internal, X-Ray Detectable, 1).
Next steps
- See all 6 Robert I. Chien & Assoc., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HXD, Robert I. Chien & Assoc., 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.