Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A & A Medical, Inc. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
146 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013491 | HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MO | A & A Medical, Inc. | 2001-11-19 | 28 | 0 |
| K013437 | SF SH CATHETER, MODEL R65-945 | A & A Medical, Inc. | 2001-11-19 | 33 | 0 |
| K003949 | TACKER, MODEL R65-933 | A & A Medical, Inc. | 2001-07-25 | 216 | 0 |
| K011512 | MMODIFICATION TO LAMINARIA | A & A Medical, Inc. | 2001-07-09 | 54 | 0 |
| K010510 | BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG | A & A Medical, Inc. | 2001-05-16 | 84 | 0 |
| K010789 | CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R | A & A Medical, Inc. | 2001-04-27 | 43 | 0 |
| K010056 | UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-45 | A & A Medical, Inc. | 2001-02-01 | 24 | 0 |
| K000027 | INSUFFLATION NEEDLE, MODEL R65-933 | A & A Medical, Inc. | 2000-04-03 | 89 | 0 |
| K994256 | SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 | A & A Medical, Inc. | 2000-02-03 | 48 | 0 |
| K974038 | THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GL | A & A Medical, Inc. | 1998-05-11 | 199 | 0 |
| K974138 | ROCKET ELECTRODE | A & A Medical, Inc. | 1998-01-30 | 88 | 0 |
| K974032 | ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER | A & A Medical, Inc. | 1997-12-22 | 60 | 0 |
| K973671 | ENDOCERVICAL BLOCK NEEDLE | A & A Medical, Inc. | 1997-11-26 | 61 | 0 |
| K972823 | MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER | A & A Medical, Inc. | 1997-10-10 | 72 | 0 |
| K972245 | TOM CAT F.L., TOM CAT S.L. | A & A Medical, Inc. | 1997-08-06 | 51 | 0 |
| K895551 | ROCKET BONE MARROW NEEDLE | A & A Medical, Inc. | 1989-10-06 | 23 | 0 |
| K894489 | GYNECOLOGIC EXAMINATION KIT | A & A Medical, Inc. | 1989-10-05 | 77 | 0 |
| K885274 | ROCKET ENDOCERVICAL BRUSH | A & A Medical, Inc. | 1989-03-09 | 77 | 0 |
| K883805 | ROCKET SEX CRIME KIT | A & A Medical, Inc. | 1989-01-31 | 146 | 0 |
| K884685 | ROCKET FETAL BLOOD SAMPLING TRAY | A & A Medical, Inc. | 1989-01-12 | 65 | 0 |
| K884684 | ROCKET INTRAUTERINE DEPTH SOUND | A & A Medical, Inc. | 1988-12-20 | 42 | 0 |
| K883806 | ROCKET INTRAUTERINE SOUND | A & A Medical, Inc. | 1988-10-31 | 54 | 0 |
| K884042 | ROCKET CERVICAL SPATULA | A & A Medical, Inc. | 1988-10-07 | 11 | 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