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

Dravon Medical, Inc. — Predicate Candidate Screening

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

59 daysmedian FDA review time

121 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K873455	S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS	Dravon Medical, Inc.	1987-09-14	17
K860770	AM-100 I/A AMPAC	Dravon Medical, Inc.	1986-04-21	49
K832739	STEDIFLO INFUSION SET	Dravon Medical, Inc.	1983-12-22	129
K831842	DRAVON T CLAMP	Dravon Medical, Inc.	1983-09-26	110
K812772	PERITONEAL DIALYSIS CYCLER SET (8UNIT)	Dravon Medical, Inc.	1981-10-19	14
K812771	PERITONEAL DIALYSIS DRAINAGE	Dravon Medical, Inc.	1981-10-19	14
K811851	S-610 SHUNT ADAPTOR SET	Dravon Medical, Inc.	1981-08-31	61
K800435	HEMOSTATIC/TUBE OCCLUDING FORCEPS	Dravon Medical, Inc.	1980-03-12	14
K782057	CATHETER, RADIOPAQUE TENCKHOFF	Dravon Medical, Inc.	1979-02-27	82
K782058	CATHETER, BETA-CAP-PERITONEAL	Dravon Medical, Inc.	1979-02-27	82
K781755	DAP-PAK	Dravon Medical, Inc.	1979-02-15	121
K780079	CANNULA, ARTERY, RENAL	Dravon Medical, Inc.	1978-02-13	28
K771097	FORCEP, DISP., A CLAMP	Dravon Medical, Inc.	1977-07-14	24
K760952	TERASAKI LYMPHOCYTE TRANSPORT KIT	Dravon Medical, Inc.	1977-01-17	76
K760994	MONITOR LINE W/FILTER & NEEDLE	Dravon Medical, Inc.	1977-01-06	59
K760995	DECOLLATING TRAY	Dravon Medical, Inc.	1977-01-06	59

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