Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Cystocope Makers, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
97 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832040 | STERILE FLUID PRODUCING UNIT #EP550 | American Cystocope Makers, Inc. | 1983-09-29 | 97 | 0 |
| K812637 | ACMI BIPOLAR HEMOSTATIC SOURCE | American Cystocope Makers, Inc. | 1981-10-26 | 41 | 0 |
| K811218 | ACMI ASPIRATOR KIT #8808 | American Cystocope Makers, Inc. | 1981-07-01 | 58 | 0 |
| K803214 | ACMI BIPOLAR HEMOSTATIC ELECTRODE | American Cystocope Makers, Inc. | 1981-01-15 | 28 | 0 |
| K791182 | ACMI RIGI-FLEX NEPHORSCOPE | American Cystocope Makers, Inc. | 1979-07-30 | 35 | 0 |
| K770754 | DUODENOSCOPE, MOLEL TX-6 | American Cystocope Makers, Inc. | 1977-04-28 | 3 | 0 |
| K760822 | MODEL TX-8 PANENDOSCOPE | American Cystocope Makers, Inc. | 1976-10-21 | 8 | 0 |
| K760451 | AIR WATER SOURCE (ACMI MODEL 710) | American Cystocope Makers, Inc. | 1976-08-30 | 14 | 0 |
| K760452 | COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92) | American Cystocope Makers, Inc. | 1976-08-30 | 14 | 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