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

Kli — Predicate Candidate Screening

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

13 daysmedian FDA review time

64 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K800822	CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE	Kli	1980-06-17	64
K800913	GYNECOLOGICAL CYSTO/URETHROSCOPE	Kli	1980-05-14	23
K781913	INSUFFALATOR LAPARAOSCOPIC	Kli	1978-12-04	20
K781109	FORCEPS, ELECTROSURGICAL	Kli	1978-09-14	76
K781089	ONE INCISION BI-POLAR ELECTRO. FORCEPS	Kli	1978-07-17	18
K780955	SCISSORS, HOOK, ELECTROSURGICAL	Kli	1978-06-22	13
K780954	SCISSORS, HOOK, ELECTROSURGICAL	Kli	1978-06-22	13
K772297	INSUFFLATOR, MODEL G100 & 200	Kli	1978-01-05	23
K772242	LAPAROSCOPY CONSOLE MODEL VIII	Kli	1977-12-20	12
K772220	PROBE, COAGULATION ACCESSORY	Kli	1977-12-13	8
K772185	LAPAROSCOPE W/REMOVABLE OPTICS	Kli	1977-11-30	5
K771962	CAMERA ADAPTER FOR ENDOSCOPES	Kli	1977-11-21	35
K771963	SINGLE INCISION TUBAL OCCLU. BAND APPL.	Kli	1977-10-25	8
K771961	DUAL INCISION TUBAL OCCLUS. BAND APPLI.	Kli	1977-10-25	8
K771960	TUBAL OCCLUSION INSERTER/LAPAROSCOPE	Kli	1977-10-25	8
K771964	8MM TROCAR & CANNUAL W/STOPCOCK	Kli	1977-10-25	8
K771959	8MM SELF-SEALING TROCAR & CANNULA	Kli	1977-10-25	8
K771958	12MM SELF-SEALING TROCAR & CANNULA	Kli	1977-10-25	8

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