Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Custom Services Intl., Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
163 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972429 | INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 | Custom Services Intl., Inc. | 1997-09-10 | 75 | 0 |
| K972430 | EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 | Custom Services Intl., Inc. | 1997-09-10 | 75 | 0 |
| K972428 | EXTRAWEAR, GENTLEMEN'S CHOICE | Custom Services Intl., Inc. | 1997-08-25 | 59 | 0 |
| K972427 | INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK | Custom Services Intl., Inc. | 1997-08-20 | 54 | 0 |
| K970791 | INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE | Custom Services Intl., Inc. | 1997-06-03 | 91 | 0 |
| K970767 | CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH | Custom Services Intl., Inc. | 1997-06-02 | 91 | 0 |
| K963319 | OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,AP | Custom Services Intl., Inc. | 1997-01-22 | 163 | 0 |
| K963322 | OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,A | Custom Services Intl., Inc. | 1997-01-22 | 163 | 0 |
| K963321 | OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,A | Custom Services Intl., Inc. | 1997-01-22 | 163 | 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