Atlas FDA

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

Mir Medical Intl. Research Srl · Predicate Candidate Screening

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

165 daysmedian FDA review time
279 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K130784SPIROTELMir Medical Intl. Research Srl2013-10-302230
K122384MINISPIRMir Medical Intl. Research Srl2012-10-04590
K081033MIROXIMir Medical Intl. Research Srl2009-01-152790
K082766MODIFICATION TO MINISPIR, SPIROLAB IIIMir Medical Intl. Research Srl2008-12-17860
K072979SPIROBANK GMir Medical Intl. Research Srl2007-12-26650
K061875MINISPIR; SPIROLAB IIIMir Medical Intl. Research Srl2006-12-111610
K061712SPIROBANK IIMir Medical Intl. Research Srl2006-12-011650
K052140SPIROLAB, SPIROLAB IIMir Medical Intl. Research Srl2006-03-162200
K043528SPIROTELMir Medical Intl. Research Srl2005-07-192100
K983909MIR SPIROBANK SPIROMETERMir Medical Intl. Research Srl1998-12-21480

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