Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
The Healthcare Group Laboratories, Inc. · Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
161 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850035 | EMPTY SOLUTION TRANSFER CONTAINER | The Healthcare Group Laboratories, Inc. | 1985-06-07 | 151 | 0 |
| K842170 | EMPTY SOLUTION TRANSFER CONTAINER | The Healthcare Group Laboratories, Inc. | 1984-10-19 | 148 | 0 |
| K842091 | DISPOS. ACU-CUT SOFT TISSUE BIOPSY | The Healthcare Group Laboratories, Inc. | 1984-07-23 | 60 | 0 |
| K840742 | RIGHT ATRIAL CATHETER | The Healthcare Group Laboratories, Inc. | 1984-07-13 | 161 | 0 |
| K830299 | SOLUTION TRANSFER CONTAINER | The Healthcare Group Laboratories, Inc. | 1983-02-19 | 22 | 0 |
| K822307 | ADHESIVE SPRAY #4050-4060 | The Healthcare Group Laboratories, Inc. | 1982-09-24 | 52 | 0 |
| K822059 | SHOW'RBAG | The Healthcare Group Laboratories, Inc. | 1982-07-22 | 9 | 0 |
| K821480 | RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT | The Healthcare Group Laboratories, Inc. | 1982-06-17 | 30 | 0 |
| K821230 | SOFTIC 49 | The Healthcare Group Laboratories, Inc. | 1982-05-28 | 31 | 0 |
| K821162 | ADHESIVE REMOVER | The Healthcare Group Laboratories, Inc. | 1982-05-14 | 18 | 0 |
| K821161 | EXTERNAL URINARY MALE INCONTINENCE DEV | The Healthcare Group Laboratories, Inc. | 1982-05-10 | 14 | 0 |
| K821171 | URINARY COLLECTION CONTAINER/LEG BAG | The Healthcare Group Laboratories, Inc. | 1982-05-10 | 14 | 0 |
| K821172 | EXTERNAL FEMALE URINARY INCONTINENCE | The Healthcare Group Laboratories, Inc. | 1982-05-10 | 14 | 0 |
| K802585 | FEEDING TUBES IN SILICONE 5,6,8&10 SIZES | The Healthcare Group Laboratories, Inc. | 1980-10-31 | 11 | 0 |
| K801785 | URETHRAL CATHETERIZATION TRAYS | The Healthcare Group Laboratories, Inc. | 1980-10-21 | 85 | 0 |
| K801787 | URINARY CATHETER CARE TRAYS #3700&3710 | The Healthcare Group Laboratories, Inc. | 1980-10-21 | 85 | 0 |
| K800954 | DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID | The Healthcare Group Laboratories, Inc. | 1980-10-03 | 163 | 0 |
| K800956 | DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN | The Healthcare Group Laboratories, Inc. | 1980-10-03 | 163 | 0 |
| K801786 | URINE COLLECTION CONTAINERS, #3600 &3610 | The Healthcare Group Laboratories, Inc. | 1980-09-30 | 64 | 0 |
| K801781 | CATHETER IRRIGATION SYRINGES, #3100,3110 | The Healthcare Group Laboratories, Inc. | 1980-08-13 | 16 | 0 |
| K801782 | GENERAL PURPOSE IRRIGATING/ASPIR SYR. | The Healthcare Group Laboratories, Inc. | 1980-08-13 | 16 | 0 |
| K801783 | CATHETER IRRIGATION TRAYS, #3300, 3310 & | The Healthcare Group Laboratories, Inc. | 1980-08-13 | 16 | 0 |
| K801784 | URINARY CATHETERS #3400,3410 &3420 | The Healthcare Group Laboratories, Inc. | 1980-08-13 | 16 | 0 |
| K800957 | DOUCHE UNIT-1500 ML DISP. CONTAINER | The Healthcare Group Laboratories, Inc. | 1980-07-14 | 82 | 0 |
| K800955 | TUBE FEEDING CONTAINER 1500 ML DISPOSE. | The Healthcare Group Laboratories, Inc. | 1980-05-30 | 37 | 0 |
| K800959 | LARGE VOLUME ENEMA CONTAINER DISPOSABLE | The Healthcare Group Laboratories, Inc. | 1980-05-14 | 21 | 0 |
| K800960 | 1500 ML DISPOSABLE ENEMA CONTAINER(1110) | The Healthcare Group Laboratories, Inc. | 1980-05-14 | 21 | 0 |
| K800961 | ENEMA CONTAINER DISP. FOR EMEMA ADMIN. | The Healthcare Group Laboratories, Inc. | 1980-05-14 | 21 | 0 |
| K800958 | PERSONAL SITZ BATH KIT | The Healthcare Group Laboratories, Inc. | 1980-05-02 | 9 | 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