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

Wells Johnson Co. — Predicate Candidate Screening

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

73 daysmedian FDA review time

316 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K991437	WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00	Wells Johnson Co.	1999-08-30	126
K984448	BIRCOLL BALLOON DISSECTOR	Wells Johnson Co.	1999-01-28	45
K971580	UAS ULTRASONIC ASPIRATOR SYSTEM	Wells Johnson Co.	1997-12-09	223
K945876	WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT	Wells Johnson Co.	1995-12-04	368
K945500	WELLS JOHNSON FIXATION SYSTEM	Wells Johnson Co.	1995-09-21	316
K951519	WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT	Wells Johnson Co.	1995-06-14	72
K945877	WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT	Wells Johnson Co.	1995-03-02	91
K945805	WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE	Wells Johnson Co.	1994-12-13	15
K854068	EXTERNAL MECHANICAL FASTENER	Wells Johnson Co.	1985-11-22	49
K843188	WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP	Wells Johnson Co.	1984-09-20	38
K832521	PLASTIC SUCTION TIPS	Wells Johnson Co.	1983-10-20	73
K832274	ASPIRATOR	Wells Johnson Co.	1983-10-20	100
K832520	SUCTION TIPS	Wells Johnson Co.	1983-10-20	73
K832519	ASPIRATING TUBING	Wells Johnson Co.	1983-10-20	73
K832273	SURGICAL STOCKINGS	Wells Johnson Co.	1983-10-19	99

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