Burton Medical Products Corp.
Chatsworth, CA, US
Burton Medical Products Corp. appears in FDA device records in Chatsworth, CA. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Burton Medical Products Corp. between 1985 and 2010. The busiest year on record is 1994, with 3. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 2 |
| 1989 | 2 |
| 1990 | 1 |
| 1993 | 1 |
| 1994 | 3 |
| 1996 | 2 |
| 2000 | 1 |
| 2004 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K101537 | AIM 200, MAJOR SURGICAL LIGHT | FSY | Substantially Equivalent | |
| K042395 | OUTPATIENT III MINOR SURGERY LIGHT | FSY | Substantially Equivalent | |
| K000639 | VISIONARY 2000 | FSY | Substantially Equivalent | |
| K963682 | GENIE' SINGLE CEILING AND DOUBLE CEILING | FSY | Substantially Equivalent | |
| K961843 | GENIE | FSY | Substantially Equivalent | |
| K935102 | SATURN LIGHT | FTA | Substantially Equivalent | |
| K942553 | GENESIS | FTD | Substantially Equivalent | |
| K936088 | WAVE FLUORESCENT MAGNIFIER | KZF | Substantially Equivalent | |
| K931645 | HALUX TASKLIGHT | KZF | Substantially Equivalent | |
| K901706 | LIGHT, HEAD, EXAMINATION | KZF | Substantially Equivalent | |
| K893808 | MODEL 0450000, OPAL MEDICAL EXAM LIGHT | KZF | Substantially Equivalent | |
| K893807 | MODEL 0183010, PEARL MEDICAL EXAM LIGHT | KZF | Substantially Equivalent | |
| K861289 | BASIC LIGHT | KZF | Substantially Equivalent | |
| K860088 | PL EXAM LIGHT | FTD | Substantially Equivalent | |
| K851742 | MEDICAL EXAMINATION LIGHTS | KZF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0589-04 | All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 Model 100580 SGL Trolley, Serial No.''s less than TRS962633 Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354. | Pivot joint on these ceiling mount lights may fail and lights may fall onto patients. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain