Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cuda Products Co. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
178 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983277 | LIGHTSOURCE OR ILLUMINATOR MODEL I-100 | Cuda Products Co. | 1998-12-16 | 90 | 0 |
| K981962 | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | Cuda Products Co. | 1998-08-18 | 75 | 0 |
| K981469 | CERMAX300 LIGHTSOURCE | Cuda Products Co. | 1998-07-09 | 77 | 0 |
| K980350 | VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 | Cuda Products Co. | 1998-04-28 | 90 | 0 |
| K980166 | LIGHTSOURCE OR ILLUMINATOR | Cuda Products Co. | 1998-04-01 | 75 | 0 |
| K961074 | LIGHTSOURCE OR ILLUMINATOR | Cuda Products Co. | 1996-04-30 | 43 | 0 |
| K951019 | INTRAORAL VIDEO SCOPE AND WINDOW TUBE | Cuda Products Co. | 1995-05-10 | 64 | 0 |
| K943731 | VIDEO OTOSCOPE | Cuda Products Co. | 1994-10-11 | 70 | 0 |
| K935818 | ENDOSCOPE | Cuda Products Co. | 1994-07-13 | 223 | 0 |
| K933369 | CUDA PRODUCTS CORP. LIGHTSOURCES | Cuda Products Co. | 1994-01-03 | 178 | 0 |
| K934337 | CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE | Cuda Products Co. | 1993-11-18 | 72 | 0 |
| K901491 | CUDA SURGICAL LIGHT | Cuda Products Co. | 1990-06-18 | 81 | 0 |
| K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE | Cuda Products Co. | 1990-04-23 | 48 | 0 |
| K894962 | CO2 LASER BRONCHOSCOPE COUPLER | Cuda Products Co. | 1989-09-28 | 52 | 0 |
| K893491 | MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300 | Cuda Products Co. | 1989-06-22 | 49 | 0 |
| K893458 | FIBEROPTIC HEADLIGHT SYSTEM | Cuda Products Co. | 1989-06-22 | 51 | 0 |
| K873598 | LASER LAPAROSCOPY SET | Cuda Products Co. | 1988-01-20 | 138 | 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