Atlas FDA

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

Helio Medical Supplies, Inc. · Predicate Candidate Screening

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

115 daysmedian FDA review time
156 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K080221EA STIMULATORHelio Medical Supplies, Inc.2008-09-092240
K072778BRIO ACUPUNCTURE NEEDLESHelio Medical Supplies, Inc.2007-11-19520
K062448LYRA ACUPUNCTURE NEEDLESHelio Medical Supplies, Inc.2006-09-20290
K052723SEVEN STAR NEEDLEHelio Medical Supplies, Inc.2006-01-131060
K050295PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLESHelio Medical Supplies, Inc.2005-03-25460
K043277C&G ACUPUNCTURE NEEDLEHelio Medical Supplies, Inc.2005-02-08740
K024207VINCO BRAND ACUPUNCTURE NEEDLEHelio Medical Supplies, Inc.2003-04-141150
K012583ACUGLIDE BRAND ACUPUNCTURE NEEDLESHelio Medical Supplies, Inc.2001-12-111230
K991507KANGNIAN BRAND ACUPUNCTURE NEEDLEHelio Medical Supplies, Inc.1999-08-271200
K991508ACUMASTER BRAND ACUPUNCTURE NEEDLEHelio Medical Supplies, Inc.1999-08-271200
K961339CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLESHelio Medical Supplies, Inc.1996-07-03860
K960036FIRARD II/ TDP LAMPHelio Medical Supplies, Inc.1996-06-061560

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