Atlas FDA

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

Innovative Surgical Products, Inc. — Predicate Candidate Screening

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

35 daysmedian FDA review time
96 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K843041HESLIN DISPOS. TUBING SETInnovative Surgical Products, Inc.1984-11-211110
K840695PHACOEMULSIFICATION KITSInnovative Surgical Products, Inc.1984-05-22960
K840693DISPOSABLE SCLERAL GLOBE PLUGInnovative Surgical Products, Inc.1984-05-22960
K840694LENS INSERTION GLIDEInnovative Surgical Products, Inc.1984-05-09830
K841072IRRIGATION, ASPIRATION TUBING SETSInnovative Surgical Products, Inc.1984-03-29170
K832235DISPOSABLE VITRECTOMY HANDPIECEInnovative Surgical Products, Inc.1983-09-29800
K821496DISPOSABLE IRRIGA/ASPIR. SYSTEMInnovative Surgical Products, Inc.1982-06-22340
K820765PLEURAL DRAINAGE RESERVOIRInnovative Surgical Products, Inc.1982-04-15240
K820680DISPOSABLE TUBING SETSInnovative Surgical Products, Inc.1982-04-09290
K802973ISPVAC TMInnovative Surgical Products, Inc.1980-12-19310
K801350ACUVAC(TM) SUCTION RESERVOIR 400CC ANDInnovative Surgical Products, Inc.1980-07-14350
K801382DISPOSABLE SURGICAL HEAD SUPPORTInnovative Surgical Products, Inc.1980-06-26140

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