Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Continuum Biomedical, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
272 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992013 | DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER | Continuum Biomedical, Inc. | 1999-09-08 | 85 | 0 |
| K983054 | MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: Y | Continuum Biomedical, Inc. | 1999-02-10 | 162 | 0 |
| K973719 | MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YA | Continuum Biomedical, Inc. | 1997-12-23 | 84 | 0 |
| K970808 | MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER | Continuum Biomedical, Inc. | 1997-09-05 | 184 | 0 |
| K971903 | SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:Y | Continuum Biomedical, Inc. | 1997-08-21 | 90 | 0 |
| K971879 | SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER | Continuum Biomedical, Inc. | 1997-08-14 | 85 | 0 |
| K970934 | CB ERBIUM/2.94(TM) ER:YAG LASER | Continuum Biomedical, Inc. | 1997-06-11 | 90 | 0 |
| K963340 | MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE | Continuum Biomedical, Inc. | 1997-05-12 | 259 | 0 |
| K961006 | MEDLITE/755 ALEXANDRITE LASER SYSTEM | Continuum Biomedical, Inc. | 1996-09-11 | 183 | 0 |
| K961748 | MEDLITE/ERBIUM LASER SYSTEM | Continuum Biomedical, Inc. | 1996-07-26 | 81 | 0 |
| K954905 | CB DIODE/532 LASER SYSTEM | Continuum Biomedical, Inc. | 1996-03-29 | 156 | 0 |
| K955131 | MEDLITE LASER SYSTEM | Continuum Biomedical, Inc. | 1996-02-20 | 103 | 0 |
| K952636 | MEDLITE LASER SYSTEM | Continuum Biomedical, Inc. | 1995-07-31 | 53 | 0 |
| K942934 | CONBIO CUB-D10 COOPER LASER SYSTEM | Continuum Biomedical, Inc. | 1994-09-27 | 97 | 0 |
| K935631 | CONBIO MEDALEX LASER SYSTEM | Continuum Biomedical, Inc. | 1994-08-23 | 272 | 0 |
| K940636 | CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM | Continuum Biomedical, Inc. | 1994-05-31 | 106 | 0 |
| K940607 | CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM | Continuum Biomedical, Inc. | 1994-05-31 | 110 | 0 |
| K922577 | CONBIO-MEDLITE(TM) Q-SWITCHED ND:YAG LASER SYSTEM | Continuum Biomedical, Inc. | 1993-04-07 | 310 | 0 |
| K915497 | CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM | Continuum Biomedical, Inc. | 1992-03-06 | 88 | 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