Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Allegiance Healthcare Corp. · Predicate Candidate Screening
63 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
172 days90th percentile
63clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023673 | AIRLIFE DEMAND NASAL CANNULA | Allegiance Healthcare Corp. | 2003-05-02 | 182 | 0 |
| K023419 | TRILAMINATE DRAPES/TIBURON | Allegiance Healthcare Corp. | 2003-02-11 | 123 | 0 |
| K024120 | MODIFICATION TO TEMNO BIOPSY NEEDLES | Allegiance Healthcare Corp. | 2003-01-15 | 30 | 0 |
| K024292 | MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION | Allegiance Healthcare Corp. | 2003-01-09 | 16 | 0 |
| K024102 | DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LAB | Allegiance Healthcare Corp. | 2002-12-18 | 6 | 0 |
| K023425 | DRAPES WITH ABSORBENT REINFORCEMENT | Allegiance Healthcare Corp. | 2002-11-06 | 26 | 0 |
| K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | Allegiance Healthcare Corp. | 2002-10-11 | 52 | 0 |
| K023170 | NITRILE POWDER-FREE EXAMINATION GLOVES | Allegiance Healthcare Corp. | 2002-10-09 | 16 | 0 |
| K023167 | BREATHABLE SURGICAL GOWN | Allegiance Healthcare Corp. | 2002-10-02 | 9 | 0 |
| K012931 | GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER | Allegiance Healthcare Corp. | 2002-08-20 | 354 | 0 |
| K020818 | POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS | Allegiance Healthcare Corp. | 2002-07-05 | 114 | 0 |
| K020593 | CONVERTORS SMS POLYOLEFIN GOWN | Allegiance Healthcare Corp. | 2002-03-18 | 24 | 16 |
| K013302 | DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH | Allegiance Healthcare Corp. | 2001-12-17 | 75 | 0 |
| K012149 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHER | Allegiance Healthcare Corp. | 2001-09-24 | 76 | 0 |
| K012984 | BREATHABLE IMPERVIOUS GOWNS | Allegiance Healthcare Corp. | 2001-09-24 | 18 | 0 |
| K011721 | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES | Allegiance Healthcare Corp. | 2001-08-14 | 71 | 0 |
| K011078 | MALLEABLE SHAFT CLAMP | Allegiance Healthcare Corp. | 2001-07-13 | 95 | 0 |
| K011132 | AIRLIFE HEPA FILTER | Allegiance Healthcare Corp. | 2001-06-08 | 56 | 0 |
| K010862 | ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WIT | Allegiance Healthcare Corp. | 2001-06-07 | 77 | 0 |
| K011186 | POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES | Allegiance Healthcare Corp. | 2001-05-25 | 37 | 0 |
| K010211 | STERILE NITRILE POWDER-FREE EXAMINATION GLOVES | Allegiance Healthcare Corp. | 2001-02-15 | 23 | 0 |
| K003370 | JAMSHIDI MARROW ACQUISITION CRADLE | Allegiance Healthcare Corp. | 2000-11-22 | 23 | 0 |
| K002508 | EQUIPMENT DRAPES | Allegiance Healthcare Corp. | 2000-09-01 | 17 | 0 |
| K983299 | ALLEGIANCE GENESIS CONTAINER SYSTEM | Allegiance Healthcare Corp. | 2000-08-04 | 683 | 0 |
| K001739 | POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAIN | Allegiance Healthcare Corp. | 2000-07-27 | 49 | 0 |
| K001924 | COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTE | Allegiance Healthcare Corp. | 2000-07-14 | 21 | 8 |
| K001667 | RESOLVE SURGICAL O.R. TOWELS | Allegiance Healthcare Corp. | 2000-06-23 | 23 | 0 |
| K001141 | POWDER FREE STERILE LATEX EXAMINATION GLOVES | Allegiance Healthcare Corp. | 2000-05-09 | 29 | 0 |
| K001189 | MODIFICATION TO CONVERTORS SURGICAL GOWNS | Allegiance Healthcare Corp. | 2000-04-21 | 9 | 0 |
| K993871 | BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WR | Allegiance Healthcare Corp. | 2000-04-21 | 158 | 0 |
| K000697 | MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BRE | Allegiance Healthcare Corp. | 2000-03-30 | 29 | 0 |
| K000417 | CONVERTORS EQUIPMENT DRAPES | Allegiance Healthcare Corp. | 2000-03-17 | 38 | 0 |
| K994244 | CONVERTORS SURGICAL GOWNS, STERILE | Allegiance Healthcare Corp. | 2000-02-18 | 64 | 0 |
| K994162 | POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CON | Allegiance Healthcare Corp. | 2000-02-09 | 62 | 0 |
| K993795 | CONVERTORS SURGICAL DRAPES | Allegiance Healthcare Corp. | 2000-01-12 | 64 | 0 |
| K993833 | AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS | Allegiance Healthcare Corp. | 1999-12-10 | 28 | 0 |
| K991205 | ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEI | Allegiance Healthcare Corp. | 1999-10-13 | 187 | 0 |
| K992951 | CONVERTORS SURGICAL GOWNS | Allegiance Healthcare Corp. | 1999-09-22 | 21 | 0 |
| K992171 | COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEI | Allegiance Healthcare Corp. | 1999-09-14 | 78 | 0 |
| K983719 | BIOSHIELD EXPRESS STERILIZATION WRAP | Allegiance Healthcare Corp. | 1999-08-25 | 308 | 0 |
| K992514 | CONVERTORS BREATHABLE SURGICAL GOWNS | Allegiance Healthcare Corp. | 1999-08-12 | 15 | 0 |
| K991992 | ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES | Allegiance Healthcare Corp. | 1999-07-13 | 29 | 0 |
| K991928 | MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLD | Allegiance Healthcare Corp. | 1999-06-25 | 17 | 0 |
| K991589 | FLEXIBLE VASCULAR CLAMP, VERSION 2 | Allegiance Healthcare Corp. | 1999-05-18 | 11 | 0 |
| K991484 | AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 | Allegiance Healthcare Corp. | 1999-05-13 | 15 | 0 |
| K991034 | CONVERTORS SURGICAL GOWNS | Allegiance Healthcare Corp. | 1999-04-16 | 18 | 0 |
| K990300 | SUPRASHIELD EXPRESS STERILIZATION WRAP | Allegiance Healthcare Corp. | 1999-02-10 | 9 | 0 |
| K982652 | ALLEGIANCE PORTA-WARM MATTRESS | Allegiance Healthcare Corp. | 1999-01-21 | 175 | 0 |
| K982369 | CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS | Allegiance Healthcare Corp. | 1998-08-24 | 48 | 0 |
| K982269 | CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, | Allegiance Healthcare Corp. | 1998-07-23 | 24 | 0 |
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