Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Chiron Vision Corp. — Predicate Candidate Screening

34 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

95 daysmedian FDA review time
358 days90th percentile
34clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970727MPORT FOLDABLE LENS PLACEMENT SYSTEMChiron Vision Corp.1997-12-172920
K972808HANSATOME MICROKERATOMEChiron Vision Corp.1997-10-24880
K960414SYNERGIST POWER PACKChiron Vision Corp.1996-04-24860
K944993IOLAB.SITE CD PHACOEMULSIFICATION MODULEChiron Vision Corp.1995-10-123650
K944995IOLAB/SITE PERISTALTIC MODULEChiron Vision Corp.1995-10-053580
K951292PASSPORT FOLDABLE LENS PLACEMENT SYSTEMChiron Vision Corp.1995-06-02720
K944994IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTEChiron Vision Corp.1995-03-141530
K941550AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENTChiron Vision Corp.1994-11-222370
K935233IOLAB LACRIMAL DUCT CATHETERChiron Vision Corp.1994-09-153180
K925606OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERSChiron Vision Corp.1994-08-296620
K926412MICRON-SCOPE IIChiron Vision Corp.1994-07-195750
K932600MODIFIED SITE POWER HANDPIECE IIChiron Vision Corp.1994-01-252420
K924198MODIFIED SITE FIBER OPTIC MODULEChiron Vision Corp.1992-11-23950
K922595MODIFIED SITE MACROBORE PHACO NEEDLEChiron Vision Corp.1992-08-31900
K922996MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICSChiron Vision Corp.1992-07-27350
K921607IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USEChiron Vision Corp.1992-06-30880
K922077MODIFIED SITE POWER HANDPIECEChiron Vision Corp.1992-06-23500
K885164LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEMChiron Vision Corp.1989-01-10280
K883199MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEMChiron Vision Corp.1988-09-15490
K871245LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1Chiron Vision Corp.1987-05-07410
K854197IOSERT LENS IMPLANT INSTRUMENTChiron Vision Corp.1986-01-22990
K843276IOCARE CONVERTER KITChiron Vision Corp.1985-05-092620
K844666SITE ULTRASONIC EMULSIFICATION MODULE OPChiron Vision Corp.1984-12-27270
K843277IOCARE PHACOEMULSIFICATION PACKChiron Vision Corp.1984-11-27990
K843275IOCARE IRRIGATION/ASPIRATION PACKChiron Vision Corp.1984-11-27990
K843278IOCARE ULTRASONIC TITANIUM TIPSChiron Vision Corp.1984-11-27990
K843039SITE ANTERIOR CAPSULOTOMERChiron Vision Corp.1984-11-211110
K842859MICROSCOPE MITTS SUPPORT TRAY COVERChiron Vision Corp.1984-10-05740
K842458SITE SIMCOE STYLE I/A HANDPIECEChiron Vision Corp.1984-08-15540
K842459SITE GILLS STYLE I/A HANDPIECEChiron Vision Corp.1984-08-15540
K840965SITE COAXIAL I/A HANDPIECE 30 TIPChiron Vision Corp.1984-05-09640
K834340IOCARE IRRIGATION & ASPIRATION PACKChiron Vision Corp.1984-04-051150
K831312LOPEZ-HORN CARRIERChiron Vision Corp.1983-05-25330
K802651POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)Chiron Vision Corp.1980-12-17540

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