Atlas FDA

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

Rocket Medical Plc · Predicate Candidate Screening

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

89 daysmedian FDA review time
250 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K210509Rocket Platinum Cured CathterRocket Medical Plc2021-09-091990
K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc2017-08-172650
K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitRocket Medical Plc2016-11-14730
K152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetRocket Medical Plc2016-03-292440
K123033ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, RORocket Medical Plc2013-02-011260
K052365CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGERocket Medical Plc2005-10-17490
K042264GUIDEWIRESRocket Medical Plc2004-11-24930
K040189ENDOMETRIAL SAMPLING SYRINGERocket Medical Plc2004-10-042500
K032015EMBRYON ULTRASOUND NEEDLE GUIDERocket Medical Plc2003-08-08390
K000340HYSTALOG HSG CATHETERRocket Medical Plc2000-04-19760
K000205EMBRYON SINGLE AND DOUBLE LUMEN NEEDLESRocket Medical Plc2000-04-19890
K994344NEUROTHERM RF CANNULARocket Medical Plc2000-03-21900
K000656EMBRYON GIFT TRANSFER CATHETERS/SETSRocket Medical Plc2000-03-09100
K000394CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNITRocket Medical Plc2000-02-29220
K994327EMBRYON TRANSFER CATHETERS/SETSRocket Medical Plc2000-02-28680
K980061EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRRocket Medical Plc1998-03-02540
K972856ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLSRocket Medical Plc1998-02-111940
K972867CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNITRocket Medical Plc1997-10-24810
K961287ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEMRocket Medical Plc1996-07-261140

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