Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Site Microsurgical Systems, Inc. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
212 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925828 | MODIFIED SITE TXR SYSTEMS | Site Microsurgical Systems, Inc. | 1994-02-16 | 457 | 0 |
| K925921 | MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE | Site Microsurgical Systems, Inc. | 1993-12-06 | 378 | 0 |
| K931866 | SITE'S CD II PHACOEMULSIFICATION HANDPIECE | Site Microsurgical Systems, Inc. | 1993-11-12 | 212 | 0 |
| K921135 | IOLAB POWER I.V. POLE | Site Microsurgical Systems, Inc. | 1992-06-03 | 85 | 0 |
| K920582 | 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. | Site Microsurgical Systems, Inc. | 1992-05-08 | 88 | 0 |
| K912902 | PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE | Site Microsurgical Systems, Inc. | 1991-12-17 | 168 | 0 |
| K912739 | SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE | Site Microsurgical Systems, Inc. | 1991-08-28 | 68 | 0 |
| K910980 | SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE | Site Microsurgical Systems, Inc. | 1991-05-22 | 76 | 0 |
| K905620 | MODIFIED SITE PERISTALTIC FOOTSWITCH | Site Microsurgical Systems, Inc. | 1991-02-27 | 75 | 0 |
| K904183 | SITE PHACOEMULSIFICATION HANDPIECE | Site Microsurgical Systems, Inc. | 1990-12-05 | 84 | 0 |
| K904151 | SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE | Site Microsurgical Systems, Inc. | 1990-12-05 | 89 | 0 |
| K904186 | SITE DIAPHRAGM CASSETTE | Site Microsurgical Systems, Inc. | 1990-11-21 | 70 | 0 |
| K896943 | SITE DISPOSABLE CUTTER AND ACCESSORIES | Site Microsurgical Systems, Inc. | 1990-03-08 | 85 | 0 |
| K895663 | SITE 810E PHOTOCOAGULATOR AND ACCESSORIES | Site Microsurgical Systems, Inc. | 1989-12-04 | 75 | 0 |
| K892852 | SITE PHACO PLUS INFUSION SLEEVE | Site Microsurgical Systems, Inc. | 1989-06-08 | 51 | 0 |
| K892911 | SITE PERISTALTIC CASSETTE | Site Microsurgical Systems, Inc. | 1989-05-17 | 27 | 0 |
| K883926 | .2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND. | Site Microsurgical Systems, Inc. | 1988-11-15 | 61 | 0 |
| K883975 | DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI. | Site Microsurgical Systems, Inc. | 1988-10-25 | 35 | 0 |
| K883605 | MODIFIED REUSABLE SITE FIBER OPTIC CABLE | Site Microsurgical Systems, Inc. | 1988-10-25 | 63 | 0 |
| K883099 | SITE MACROBORE PHACO NEEDLE | Site Microsurgical Systems, Inc. | 1988-09-15 | 55 | 0 |
| K883575 | MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE | Site Microsurgical Systems, Inc. | 1988-09-12 | 21 | 0 |
| K883480 | MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE | Site Microsurgical Systems, Inc. | 1988-08-24 | 8 | 0 |
| K883098 | SITE STERILIZATION TRAYS FOR OPHTHALMIC USE | Site Microsurgical Systems, Inc. | 1988-08-18 | 27 | 0 |
| K882103 | SITE ULTRASONIC I/A PHACO NEEDLE | Site Microsurgical Systems, Inc. | 1988-07-01 | 43 | 0 |
| K874725 | SITE SOLUTION ADMINISTRATION SET | Site Microsurgical Systems, Inc. | 1988-04-01 | 135 | 0 |
| K871485 | SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE | Site Microsurgical Systems, Inc. | 1987-06-03 | 49 | 0 |
| K871375 | SITE PERISTALTIC MODULE SYSTEM | Site Microsurgical Systems, Inc. | 1987-05-07 | 30 | 0 |
| K864301 | SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD) | Site Microsurgical Systems, Inc. | 1986-12-15 | 45 | 0 |
| K862943 | SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE | Site Microsurgical Systems, Inc. | 1986-08-21 | 16 | 0 |
| K861060 | SITE PHACO DISPOSABLE CASSETTE | Site Microsurgical Systems, Inc. | 1986-05-06 | 47 | 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