Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carl Zeiss, Inc. · Predicate Candidate Screening
44 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
304 days90th percentile
44clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013402 | VISULAS 532S | Carl Zeiss, Inc. | 2001-11-14 | 30 | 1 |
| K003885 | VISULAS YAG II | Carl Zeiss, Inc. | 2001-02-22 | 69 | 0 |
| K993357 | IOLMASTER | Carl Zeiss, Inc. | 2000-03-20 | 166 | 4 |
| K983868 | OPMI TWINER SURGICAL MICROSCOPE | Carl Zeiss, Inc. | 1999-01-29 | 88 | 0 |
| K965139 | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAV | Carl Zeiss, Inc. | 1997-04-23 | 121 | 0 |
| K961380 | CPC PROBE | Carl Zeiss, Inc. | 1997-03-17 | 341 | 0 |
| K961171 | HUMPHREY OCT SCANNER | Carl Zeiss, Inc. | 1996-06-21 | 88 | 0 |
| K954167 | HUMPHREY FIELD ANALYZER (HFA II) | Carl Zeiss, Inc. | 1995-11-24 | 80 | 0 |
| K952894 | VISULINK 900 ARGON | Carl Zeiss, Inc. | 1995-08-14 | 52 | 0 |
| K950985 | ZEISS ENDOLIVE STERO ENDOSCOPE | Carl Zeiss, Inc. | 1995-03-29 | 26 | 0 |
| K931478 | ZEISS OPMI L STEREO-LAPAROSCOPE | Carl Zeiss, Inc. | 1994-09-28 | 553 | 0 |
| K942233 | MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM | Carl Zeiss, Inc. | 1994-07-01 | 53 | 0 |
| K936198 | ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES | Carl Zeiss, Inc. | 1994-04-06 | 98 | 0 |
| K932376 | ZEISS OPMILAS 144 SURGICAL LASERS | Carl Zeiss, Inc. | 1993-12-14 | 211 | 0 |
| K926452 | ZEISS VISULAS YAG II LASER | Carl Zeiss, Inc. | 1993-11-22 | 333 | 0 |
| K933322 | ZEISS OPMILAS 144 SURGICAL LASERS | Carl Zeiss, Inc. | 1993-10-15 | 100 | 0 |
| K925642 | ZEISS DIODE-PUMPED SOLID STATE LASER | Carl Zeiss, Inc. | 1993-09-13 | 308 | 0 |
| K925641 | ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR | Carl Zeiss, Inc. | 1993-09-09 | 304 | 0 |
| K924588 | ZEISS LASER INDIRECT OPHTHALMOSCOPE | Carl Zeiss, Inc. | 1993-07-09 | 302 | 0 |
| K923274 | ZEISS VISULAS DIODE LASER | Carl Zeiss, Inc. | 1993-04-05 | 273 | 0 |
| K923341 | ZEISS VISULAS ARGON LASER | Carl Zeiss, Inc. | 1992-10-28 | 145 | 0 |
| K922735 | ZIESS ENDOPROBE | Carl Zeiss, Inc. | 1992-07-09 | 31 | 0 |
| K920967 | ZEISS MULTI YAG LASER | Carl Zeiss, Inc. | 1992-07-08 | 128 | 0 |
| K920120 | ND:YAG SURGICAL LASER | Carl Zeiss, Inc. | 1992-04-10 | 88 | 0 |
| K920529 | ZEISS MULTIYAG LASER | Carl Zeiss, Inc. | 1992-04-02 | 57 | 0 |
| K915840 | ZEISS MULTIYAG LASER | Carl Zeiss, Inc. | 1992-03-23 | 90 | 0 |
| K915561 | ZEISS MULTIYAG LASER | Carl Zeiss, Inc. | 1992-03-11 | 90 | 0 |
| K912581 | ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) | Carl Zeiss, Inc. | 1991-12-23 | 194 | 0 |
| K894393 | OPMILAS CO2-L | Carl Zeiss, Inc. | 1989-07-27 | 10 | 0 |
| K891584 | S 22 INSTRUMENT STAND | Carl Zeiss, Inc. | 1989-06-08 | 80 | 0 |
| K884876 | S 4 INSTRUMENT STAND | Carl Zeiss, Inc. | 1988-12-15 | 24 | 0 |
| K883581 | OPMI CS | Carl Zeiss, Inc. | 1988-09-13 | 22 | 0 |
| K883578 | S 21 INSTRUMENT STAND | Carl Zeiss, Inc. | 1988-09-13 | 22 | 0 |
| K874160 | ZEISS 40 SL/P PHOTO SLIT LAMP | Carl Zeiss, Inc. | 1988-01-27 | 106 | 0 |
| K874609 | ZEISS VISULAS ARGON LASER | Carl Zeiss, Inc. | 1988-01-06 | 58 | 0 |
| K874241 | OPMI MD SURGICAL MICROSCOPE | Carl Zeiss, Inc. | 1987-12-23 | 69 | 0 |
| K862004 | ZEISS 30 SL-L | Carl Zeiss, Inc. | 1986-06-17 | 21 | 0 |
| K860811 | ZEISS VOICE CONTROL SYSTEM FOR OPMI'S | Carl Zeiss, Inc. | 1986-04-30 | 57 | 0 |
| K854383 | KERATOLUX | Carl Zeiss, Inc. | 1985-11-12 | 13 | 0 |
| K853720 | MOBILE OPERATING TABLE FOR ORL MICROSURGERY | Carl Zeiss, Inc. | 1985-10-18 | 43 | 0 |
| K853723 | ZEISS OPERATING KERATOMETER | Carl Zeiss, Inc. | 1985-10-15 | 40 | 0 |
| K853891 | INDIRECT OPHTHALMOSCOPE | Carl Zeiss, Inc. | 1985-10-04 | 15 | 0 |
| K831074 | OSCAR COLOR VISION TESTER | Carl Zeiss, Inc. | 1983-04-28 | 24 | 0 |
| K800552 | ZEISS DISPOSABLE, STERILE SURGICAL DRAPE | Carl Zeiss, Inc. | 1980-03-20 | 10 | 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