Atlas FDA

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

Inviro Medical Devices, Inc. · Predicate Candidate Screening

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

98 daysmedian FDA review time
279 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K101359INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)Inviro Medical Devices, Inc.2010-08-20980
K092413INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGESInviro Medical Devices, Inc.2009-09-04280
K0924301 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUEInviro Medical Devices, Inc.2009-09-04280
K083851INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522Inviro Medical Devices, Inc.2009-05-151420
K081436INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGESInviro Medical Devices, Inc.2008-10-221540
K071307INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 1305Inviro Medical Devices, Inc.2008-02-122790
K070203INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 10Inviro Medical Devices, Inc.2007-04-23910

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