Atlas FDA

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

Xanar, Inc. — Predicate Candidate Screening

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

154 daysmedian FDA review time
188 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K861688XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15Xanar, Inc.1986-10-031540
K852436AMBULASEXanar, Inc.1986-04-183120
K860496MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARYXanar, Inc.1986-03-14320
K853620MODEL XA-50 - CO2 SURGICAL LASERXanar, Inc.1986-01-241480
K850805CO 2 SURGICAL LASER SYSTEM MODEL NA-40Xanar, Inc.1985-08-151690
K850818CO 2 SURGICAL LASER SYSTEM NA-120Xanar, Inc.1985-08-151680
K850804CO 2 SURGICAL LASER SYSTEM NA-30Xanar, Inc.1985-08-151690
K844087XANAR MODEL XSE-300 SMOKE EVACULATERXanar, Inc.1985-02-271280
K841860CO2 SURGICAL LASER SYSTEM XML-10Xanar, Inc.1984-11-081880
K833325AMBULASE XAM-15 XANAR SURG. LASERXanar, Inc.1984-01-261210
K837224UNKNOWNXanar, Inc.1983-05-02610
K837216MODEL XA-15 LASER SYSTEM FOR SURGERYXanar, Inc.1983-04-04350

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