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

J.F. Jelenko & Co., Inc. · Predicate Candidate Screening

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

58 daysmedian FDA review time

221 days90th percentile

55clearances measured

K-number	Device	Applicant	Decided	Review days
K012303	JEL-20	J.F. Jelenko & Co., Inc.	2001-08-22	33
K002993	HERACERAM	J.F. Jelenko & Co., Inc.	2000-11-16	52
K002645	JEL BIOS PURE	J.F. Jelenko & Co., Inc.	2000-10-19	56
K002222	RD-2104	J.F. Jelenko & Co., Inc.	2000-08-31	38
K001360	SIGNUM	J.F. Jelenko & Co., Inc.	2000-06-20	53
K001260	ALLROUND 55 LF	J.F. Jelenko & Co., Inc.	2000-05-17	28
K001196	JEL BIOS 90 (CODE NAME RD-2401)	J.F. Jelenko & Co., Inc.	2000-05-11	29
K000532	JEL 15	J.F. Jelenko & Co., Inc.	2000-04-06	49
K993152	JEL BIOS 18 (CODE NAME RD- 1214)	J.F. Jelenko & Co., Inc.	1999-10-21	30
K993136	JEL BIOS 10 (CODE NAME RD-1801)	J.F. Jelenko & Co., Inc.	1999-10-21	31
K991564	JELTEMP	J.F. Jelenko & Co., Inc.	1999-06-23	49
K990056	JELDENT MULTICRYL	J.F. Jelenko & Co., Inc.	1999-03-25	77
K984587	ALLROUND-E (CODE NAME RD 1710)	J.F. Jelenko & Co., Inc.	1999-03-17	83
K984140	MAINBOND A	J.F. Jelenko & Co., Inc.	1999-01-13	56
K981244	BW-1 (CODE NAME RD-0807)	J.F. Jelenko & Co., Inc.	1998-08-13	129
K981257	JELFINE-52 (CODE NAME RD-0901)	J.F. Jelenko & Co., Inc.	1998-08-13	129
K981247	SILCAST (CODE NAME RD-0118)	J.F. Jelenko & Co., Inc.	1998-07-01	86
K973881	PROSPECTOR PLUS (CODE NAME : RD-0508)	J.F. Jelenko & Co., Inc.	1997-11-24	41
K971575	BENCHMARK-IV	J.F. Jelenko & Co., Inc.	1997-06-04	58
K971574	JELBOND-PDF	J.F. Jelenko & Co., Inc.	1997-05-20	43
K971292	JEL-71 PDF	J.F. Jelenko & Co., Inc.	1997-05-20	43
K970068	JELENKO NO.1 (CODE NAME RD-0601)	J.F. Jelenko & Co., Inc.	1997-03-24	75
K960403	DIAMOND (CODE NAME PT-054)	J.F. Jelenko & Co., Inc.	1996-02-26	28
K960399	TOPAZ	J.F. Jelenko & Co., Inc.	1996-02-21	23
K944889	ALLROUND 4	J.F. Jelenko & Co., Inc.	1994-11-17	44
K944888	MEDALIST	J.F. Jelenko & Co., Inc.	1994-11-07	34
K944887	EUREKA PLUS	J.F. Jelenko & Co., Inc.	1994-11-07	34
K944679	JEL 96	J.F. Jelenko & Co., Inc.	1994-11-07	46
K933623	EUREKA	J.F. Jelenko & Co., Inc.	1994-02-01	197
K932130	FREEDOM PLUS (CODE NAME MISC-LIB-013)	J.F. Jelenko & Co., Inc.	1993-07-08	66
K930601	FREEDOM	J.F. Jelenko & Co., Inc.	1993-03-31	54
K923714	SYMPHONY	J.F. Jelenko & Co., Inc.	1993-03-16	232
K923717	JELENKO PORCELAIN SYSTEM PVS PROCELAIN	J.F. Jelenko & Co., Inc.	1993-03-16	232
K923817	ULTRAGOLD	J.F. Jelenko & Co., Inc.	1993-03-11	224
K923719	SUNCAST D-KF	J.F. Jelenko & Co., Inc.	1993-03-05	221
K923716	JEL-0-75	J.F. Jelenko & Co., Inc.	1993-03-05	221
K923715	SUNCAST-D	J.F. Jelenko & Co., Inc.	1993-03-05	221
K923720	SUNCAST	J.F. Jelenko & Co., Inc.	1993-03-05	221
K923722	HN-40	J.F. Jelenko & Co., Inc.	1993-03-05	221
K923721	PROSPECTOR	J.F. Jelenko & Co., Inc.	1993-03-05	221
K923718	HP-3	J.F. Jelenko & Co., Inc.	1993-03-05	221
K923713	MICROSTAR	J.F. Jelenko & Co., Inc.	1993-02-26	214
K922774	COLLEGIATE	J.F. Jelenko & Co., Inc.	1992-12-04	178
K922449	PA-400	J.F. Jelenko & Co., Inc.	1992-08-05	75
K922447	BENCHMARK III	J.F. Jelenko & Co., Inc.	1992-08-05	75
K922450	BENCHMARK C	J.F. Jelenko & Co., Inc.	1992-08-05	75
K922448	BENCHMARK I	J.F. Jelenko & Co., Inc.	1992-08-05	75
K922446	ACCU-STAR	J.F. Jelenko & Co., Inc.	1992-08-05	75
K922451	LEGACY-XT	J.F. Jelenko & Co., Inc.	1992-08-05	75
K882126	JEL-5 GOLD BASED ALLOYS & PRECIOUS METAL ALLOYS	J.F. Jelenko & Co., Inc.	1988-06-13	24

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