Atlas FDA

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

Thd Spa — Predicate Candidate Screening

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

50 daysmedian FDA review time
249 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K211623THD Procto Software SystemThd Spa2021-06-24290
K193512THD Procto Software SystemThd Spa2020-01-26390
K180135THD Anopress with THD SensyProbeThd Spa2018-03-08500
K161785THD ANOPRESSThd Spa2017-03-142580
K141657THD REVOLUTIONThd Spa2015-02-242490
K133687THD N-ANO ANOSCOPEThd Spa2013-12-1190
K121135THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-Thd Spa2012-06-01490
K103647THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPESThd Spa2011-03-01780
K093497THD BANDYThd Spa2010-07-152450
K091490FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPESThd Spa2009-06-11220
K090009THD SLIDE ONEThd Spa2009-01-28260
K081429THD SLIDEThd Spa2008-07-30700
K080132THD DISPOSABLE ANOSCOPE/PROCTOSCOPEThd Spa2008-04-09820

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