Atlas FDA

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

Telediagnostic Systems, Inc. · Predicate Candidate Screening

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

77 daysmedian FDA review time
172 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071661ALPHAONE BIOFEEDBACK SYSTEMTelediagnostic Systems, Inc.2007-09-05780
K022249NIGHTRON POLYSOMNOGRAPHY SYSTEMTelediagnostic Systems, Inc.2002-12-311720
K970659DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVTelediagnostic Systems, Inc.1997-05-16840
K904328VISTA POLYSOMNOGRAPHY COMPUTER SYSTEMTelediagnostic Systems, Inc.1991-06-182710
K904222VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIERTelediagnostic Systems, Inc.1991-01-181270
K885328RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVERTelediagnostic Systems, Inc.1989-03-22840
K884891OC-100 OXIMETER INTERFACE CALIBRATORTelediagnostic Systems, Inc.1988-12-28360
K883947ISO-100 ISOLATION AMPLIFIERTelediagnostic Systems, Inc.1988-12-05770
K874257S-10 TELEPHONIC POLYSOMNOGRAPHTelediagnostic Systems, Inc.1987-12-11520
K871120M10 EEG MONITOR SCOPETelediagnostic Systems, Inc.1987-05-01430
K810872EEG TELEPHONE RECEIVER MODEL #AFR-JTelediagnostic Systems, Inc.1981-05-01310
K802656MODEL T-6 EEG TELEPHONE TRANSMITTERTelediagnostic Systems, Inc.1980-11-26330
K802657MODEL AFR EEG TELEPHONE RECEIVERTelediagnostic Systems, Inc.1980-11-12190
K780150NEONATAL SCREENING AUDIOMETERTelediagnostic Systems, Inc.1978-02-13140

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