Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Robert I. Chien & Assoc., Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
94 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K822151 | SURGICAL INSTRUMENTS REPRESENT. 4 CLASS | Robert I. Chien & Assoc., Inc. | 1982-08-19 | 28 | 0 |
| K811632 | UNSTERILIZED LAPAROTOMY SPONGES (CHINA) | Robert I. Chien & Assoc., Inc. | 1981-09-11 | 94 | 0 |
| K811631 | THERMOMETER (MADE IN CHINA) | Robert I. Chien & Assoc., Inc. | 1981-07-20 | 41 | 0 |
| K810054 | RICA (DIAGNOSTIC INSTRUMENTS) | Robert I. Chien & Assoc., Inc. | 1981-01-28 | 16 | 0 |
| K801819 | SURGICAL INSTRUMENTS | Robert I. Chien & Assoc., Inc. | 1980-08-20 | 20 | 0 |
| K801028 | RICA OR SMIC SURGICAL INSTRUMENTS | Robert I. Chien & Assoc., Inc. | 1980-05-20 | 19 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda