Atlas FDA

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

Bio-Logic Systems Corp. — Predicate Candidate Screening

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

86 daysmedian FDA review time
297 days90th percentile
45clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K122496AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMBio-Logic Systems Corp.2012-11-01770
K121512SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMBio-Logic Systems Corp.2012-07-26660
K073626BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEMBio-Logic Systems Corp.2008-02-05410
K061744COCHLEA-SCAN / COCHLEA-SCAN PLUSBio-Logic Systems Corp.2006-09-15860
K052066CEEGRAPH/SLEEPSCAN NETLINK TRAVELERBio-Logic Systems Corp.2005-08-26252
K031352BIO-LOGIC INSERT EARPHONESBio-Logic Systems Corp.2003-07-16780
K030907STACKED ABR FOR NAVIGATOR PROBio-Logic Systems Corp.2003-05-09460
K031009MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEMBio-Logic Systems Corp.2003-04-28280
K021895BIO-LOGIC MASTER EVOKED RESPONSE SYSTEMBio-Logic Systems Corp.2002-07-01210
K021801BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONSBio-Logic Systems Corp.2002-06-27240
K021215BIO-LOGIC ABAER CUBBio-Logic Systems Corp.2002-05-15280
K012384EAR MUFFINSBio-Logic Systems Corp.2001-10-15800
K003681BIO-LOGIC SLEEPSCAN NETLINKBio-Logic Systems Corp.2000-12-21210
K002570BIO-LOGIC CEEGRAPH NETLINKBio-Logic Systems Corp.2000-09-14270
K994149MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGABio-Logic Systems Corp.1999-12-27190
K992807BIO-LOGIC EVOKED POTENTIAL FOR ABAER IBio-Logic Systems Corp.1999-09-14250
K983913MODIFICATION TO BIO-LOGIC SLEEPSCANBio-Logic Systems Corp.1998-11-25210
K973883BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEMBio-Logic Systems Corp.1998-03-051420
K974076SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBEBio-Logic Systems Corp.1998-01-22850
K971501SLEEPSCAN AIRFLOW PRESSURE TRANSDUCERBio-Logic Systems Corp.1997-10-141730
K964132MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENTBio-Logic Systems Corp.1997-05-132100
K962103BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETERBio-Logic Systems Corp.1996-08-22840
K961447SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC Bio-Logic Systems Corp.1996-05-29430
K954954CEEGRAPH TRAVELER AMBULATORY EEG RECORDERBio-Logic Systems Corp.1996-01-25870
K944314DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123Bio-Logic Systems Corp.1996-01-034920
K951594BIO-LOGIC AUTOMATIC EVENT ANALYSISBio-Logic Systems Corp.1995-08-221380
K941799DISPOSABLE CUTANEOUS ELECTRODESBio-Logic Systems Corp.1995-02-032970
K941928VARIOUS ELECTRODESBio-Logic Systems Corp.1995-02-032890
K944735BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TESTBio-Logic Systems Corp.1994-12-21860
K933233CEEGRAPH, MODIFICATIONBio-Logic Systems Corp.1994-03-033160
K930790ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.Bio-Logic Systems Corp.1994-01-063240
K930328NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCTBio-Logic Systems Corp.1993-07-021610
K893130EMG NAVIGATOR & EMG TRAVELERBio-Logic Systems Corp.1990-03-203290
K895125CEEGRAPHBio-Logic Systems Corp.1989-12-221290
K874136PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTALBio-Logic Systems Corp.1988-03-251640
K872290BIO-LOGIC BANKERBio-Logic Systems Corp.1987-10-061120
K870337AUDIOMETERBio-Logic Systems Corp.1987-04-16780
K862690TRAVELER LTBio-Logic Systems Corp.1986-11-251330
K854362MODIFIED BRAIN ATLAS IIIBio-Logic Systems Corp.1986-04-221750
K852533L.E.D. GOGGLES, MODEL 580-LEDGOGBio-Logic Systems Corp.1985-12-121810
K850180ELECTRONYSTAGMOGRAPH (ENG RECORDER)Bio-Logic Systems Corp.1985-07-221860
K844992BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEMBio-Logic Systems Corp.1985-06-071630
K842543EVOKED POTENTIAL SYSBio-Logic Systems Corp.1984-11-291500
K831047BIOLOGIC SYSTEM BL 101Bio-Logic Systems Corp.1983-05-13430
K803226EVOKED RESPONSE STIMULATORSBio-Logic Systems Corp.1981-02-05480

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