Atlas FDA

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

Carolina Medical Electronics — Predicate Candidate Screening

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

49 daysmedian FDA review time
165 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K914200VASCUMAP MEDICAL AIR PLETHYSMOGRAPHCarolina Medical Electronics1991-11-07490
K874685TRANS-SCAN 3-D TRANSCRANIAL DOPPLERCarolina Medical Electronics1988-04-251650
K874684TC2-64B TRANSCRANIAL DOPPLERCarolina Medical Electronics1988-04-251650
K864624PROBE, UPTAKE, NUCLEARCarolina Medical Electronics1987-08-102580
K843891DOPSCAN PLUS DS1060Carolina Medical Electronics1985-01-09990
K837329SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUNDCarolina Medical Electronics1983-06-07910
K820272CLINIFLOW II, #701, ELECTROMAGN. BLD. SYCarolina Medical Electronics1982-03-12380
K810561DOPSCAN MODEL 1050Carolina Medical Electronics1981-04-10380
K801647SONACOLOR 6100Carolina Medical Electronics1980-08-20330
K792540SONACOLOR 6000Carolina Medical Electronics1980-01-17380
K772015PATIENT HEATER SYSTEM, MODEL PH112Carolina Medical Electronics1977-11-15210

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