Atlas FDA

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

Ela Medical, Inc. · Predicate Candidate Screening

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

106 daysmedian FDA review time
233 days90th percentile
43clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K042002SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADEREla Medical, Inc.2004-10-20860
K032466SPIDERVIEWEla Medical, Inc.2003-08-22110
K002817SYNETECEla Medical, Inc.2001-05-022330
K993448STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJEla Medical, Inc.2000-04-101810
K000029STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJEla Medical, Inc.2000-04-04900
K990727SYNEFLASH & SYNEVIEWEla Medical, Inc.1999-11-262660
K972574STELA MODEL UJ45 PACING LEADSEla Medical, Inc.1998-01-081820
K970072OPUS S MODEL 4121 AND 4124 PACEMAKERSEla Medical, Inc.1997-08-292330
K963738STELA MODEL BJ44 AND BJ45 PACING LEADSEla Medical, Inc.1997-05-232480
K952364OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)Ela Medical, Inc.1995-09-011230
K952363OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)Ela Medical, Inc.1995-08-151060
K896742FOCUS J81F, J83F, J41F, J43F PACING LEADSEla Medical, Inc.1990-07-172290
K895806ELATEC HOLTER ANALYZEREla Medical, Inc.1990-04-041880
K900461OPUS MODEL 4021, VVI, 5MM UNIPOLAREla Medical, Inc.1990-03-14420
K894065OPUS MODEL 4001Ela Medical, Inc.1989-09-261100
K894267OPUS MODELS 4033 AND 4034Ela Medical, Inc.1989-09-20900
K890018PACEMAKER LEAD ADAPTEREla Medical, Inc.1989-06-201680
K883037UNILITH 3 MODELS 7580/7583/7680/7683Ela Medical, Inc.1989-01-251900
K884394PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84FEla Medical, Inc.1988-12-08550
K882391OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024Ela Medical, Inc.1988-11-141570
K882427CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066Ela Medical, Inc.1988-09-231020
K882476OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004Ela Medical, Inc.1988-09-12890
K882474OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004Ela Medical, Inc.1988-09-12890
K872731PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860Ela Medical, Inc.1987-09-15690
K863898MULTILITH 3 MODELS 1350, 3350, 1370, 3370Ela Medical, Inc.1987-02-101260
K852973UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762Ela Medical, Inc.1986-03-312590
K851731ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860Ela Medical, Inc.1985-08-291260
K853017ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251Ela Medical, Inc.1985-07-2580
K842193MULTILITH PULSE GENERATORS, 1141 & 2141Ela Medical, Inc.1985-01-102200
K842220MULTILITH 2 PULSE GENERATOR 1141 & 2141Ela Medical, Inc.1984-11-291770
K830457PACING LEAD #PMA F 860Ela Medical, Inc.1983-03-17360
K830401UNILITH PULSE GENERATOR VVI #7542Ela Medical, Inc.1983-03-17380
K813246MEDICAL MULTILITH PULSE GENERA-1140Ela Medical, Inc.1982-02-12860
K810887ELA MEDICAL UNILITH 7540 PULSE GENERATOREla Medical, Inc.1981-07-201100
K810489MULTILITH PULSE GENERATOR #1140Ela Medical, Inc.1981-05-29950
K810142ELA MEDICAL UNILITH PULSE GENERATOREla Medical, Inc.1981-05-291280
K810626ELA MEDICAL PACING LEAD MODEL PMA 860Ela Medical, Inc.1981-03-0900
K792602SUSI II PACEMAKER SURVEILLANCE MONITOREla Medical, Inc.1980-03-25980
K791975PACING SYSTEM ANALYZER PSA SCE-22Ela Medical, Inc.1980-01-311210
K792239ELA MEDICAL ANATEC HOLTER SCANNEREla Medical, Inc.1979-11-0700
K791219UNILITH PULSE GENERATOREla Medical, Inc.1979-07-30270
K790562PULSE GENERATOR MODEL 61 AND 128Ela Medical, Inc.1979-05-08500
K790386LEAD MODELS MUM 1260, MUM 1290Ela Medical, Inc.1979-04-03360

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