Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Singer Medical Products, Inc. · Predicate Candidate Screening

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

132 daysmedian FDA review time
176 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K905035AXOSTIM NERVE STIMULATOR, MODIFICATIONSinger Medical Products, Inc.1991-04-191760
K896909MD5 AUTOMATIC AUDIOMETERSinger Medical Products, Inc.1990-03-05840
K894748IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1PSinger Medical Products, Inc.1989-12-051320
K895783IMPEDANCE ANALYZER MODELS MD-2, MD-PSinger Medical Products, Inc.1989-12-051320
K895784IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3Singer Medical Products, Inc.1989-12-051320
K895785AUDIOMETER MODEL MD-4, MD-4PSinger Medical Products, Inc.1989-12-051320
K896368MODIFIED AXOSTIMSinger Medical Products, Inc.1989-11-27210
K883807AXOSTIMSinger Medical Products, Inc.1989-02-091540

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