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

Snowden-Pencer · Predicate Candidate Screening

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

99 daysmedian FDA review time

559 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K960400	DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LI	Snowden-Pencer	1996-03-12	43	0
K930666	REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY	Snowden-Pencer	1994-05-19	464	0
K930667	REUSABLE LAPAROSCOPIC INSTRUMENTS	Snowden-Pencer	1994-05-16	461	15
K924148	DIAMOND-SHARP(R) TROCARS	Snowden-Pencer	1994-02-28	559	0
K924149	ENDO I/A PROBE	Snowden-Pencer	1993-01-26	161	0
K920985	SNOWDEN-PENCER IRRIGATION PUMP	Snowden-Pencer	1992-06-09	99	0
K920986	SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700	Snowden-Pencer	1992-06-04	94	0
K913979	ENDO I/A Y SET	Snowden-Pencer	1991-11-27	82	0
K913835	SNOWDEN-PENCER INSUFFLATOR TUBING SET	Snowden-Pencer	1991-11-07	73	0
K861372	ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY	Snowden-Pencer	1986-06-19	69	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