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

American Optical Corp. — Predicate Candidate Screening

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

28 daysmedian FDA review time

226 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days
K950881	PHACO TIP	American Optical Corp.	1995-09-06	191
K950880	AOI UNIVERSAL ULTRASONIC HANDPIECE	American Optical Corp.	1995-05-26	88
K931358	AORP4000 REUSABLE PAK	American Optical Corp.	1994-02-22	342
K931354	P4000 PHACOEMULSIFIER	American Optical Corp.	1994-02-22	342
K931357	AOD4000 DISPOSABLE PAK	American Optical Corp.	1994-01-25	314
K820790	FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3	American Optical Corp.	1982-04-01	9
K813430	TISSUE PROCESSING CASSETTES & ACCESS	American Optical Corp.	1981-12-29	21
K812965	MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE	American Optical Corp.	1981-11-02	11
K812051	PHOTOLITE AOLITE TINTOMATIC LENS	American Optical Corp.	1981-09-08	49
K812063	SR-1V DATA PRINTER	American Optical Corp.	1981-08-18	28
K811535	MODEL FUS-1, FLEXIBLE URETEROSCOPE	American Optical Corp.	1981-06-23	22
K811180	ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ	American Optical Corp.	1981-05-15	17
K811181	MODEL FBS-1, FLEXIBLE BRONCHOSCOPE	American Optical Corp.	1981-05-13	15
K802183	SR-IV PROGRAMMED SUBJECTIVE REFRACTOR	American Optical Corp.	1981-04-23	226
K802419	AO NON-CONTACT II TONOMETER	American Optical Corp.	1980-11-12	37
K802331	AO FLEXIBLE LARYNGOSCOPE, #LS-7	American Optical Corp.	1980-10-10	17
K801638	A O CUSTOM II CHAIR AND STAND	American Optical Corp.	1980-08-13	27
K801364	AO STYLET LARYNGOSCOPE MODEL SLS	American Optical Corp.	1980-06-17	7
K801110	PRESSURE MONITOR, MODEL 1131B	American Optical Corp.	1980-05-20	8
K800192	DURALITE LENS	American Optical Corp.	1980-03-12	43
K792179	AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE	American Optical Corp.	1979-12-06	38
K792081	SPECTRA CENTRAL PT MONITORING SYS	American Optical Corp.	1979-11-13	28
K791721	ULTRAVUE BLENDED BIFOCAL LENS	American Optical Corp.	1979-10-23	54
K791635	AO TEACHING ATTACHMENT, MODEL TA-1	American Optical Corp.	1979-09-24	34
K791634	AO STYLET LARYNGOSCOPE, MODEL SLS-1	American Optical Corp.	1979-09-17	27
K790338	COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER	American Optical Corp.	1979-04-04	42
K790251	FUL-VUE ASPHERIC CATARACT LENS	American Optical Corp.	1979-02-26	20
K782118	FUL-VUE	American Optical Corp.	1979-01-26	30
K781845	CAMSCAN SYSTEM	American Optical Corp.	1978-11-20	19
K781241	UNISTAT BILIRUBINOMETER	American Optical Corp.	1978-08-14	26
K780625	UNISTAT OXIMETER	American Optical Corp.	1978-04-28	14
K780343	ARRHYTHMIA TREND ENHANCEMENT	American Optical Corp.	1978-04-18	47
K771914	SUBJECTIVE REFRACTOR, MOSEL SR-111	American Optical Corp.	1977-11-09	28
K770221	MEMLITE (PLASTIC EYEGLASS FRAMES)	American Optical Corp.	1977-02-17	14
K761163	AD7 PLASTIC MULTIFOCAL EYEGLASS LENS	American Optical Corp.	1976-12-16	15

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