Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HAO — Predicate Candidate Screening
34 FDA 510(k) clearances under this product code; the 50 most recent screened below.
25 daysmedian FDA review time
62 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220920 | Matreneu Percutaneous Balloon Compression Kit | Shenzhen Shineyard Medical Device Co. , Ltd. | 2022-09-07 | 161 | 0 |
| K940973 | MULLAN GANGLION MICROCOMPRESSION SET | Cook, Inc. | 1995-09-29 | 575 | 0 |
| K951492 | RIB RESECTOR | United States Surgical, A Division of Tyco Healthc | 1995-05-18 | 48 | 0 |
| K943115 | AUTO SUTURE PITUITARY SPINAL RONGEUR | United States Surgical, A Division of Tyco Healthc | 1994-07-25 | 28 | 0 |
| K942971 | AUTO SUTURE SPINAL DISSECTOR | United States Surgical, A Division of Tyco Healthc | 1994-07-20 | 30 | 0 |
| K942967 | AUTO SUTURE SPINAL CURETTE | United States Surgical, A Division of Tyco Healthc | 1994-07-20 | 30 | 0 |
| K942970 | AUTO SUTURE SPINAL ELEVATOR | United States Surgical, A Division of Tyco Healthc | 1994-07-20 | 30 | 0 |
| K942968 | AUTO SUTURE SPINAL OSTEOTOME | United States Surgical, A Division of Tyco Healthc | 1994-07-20 | 30 | 0 |
| K942969 | AUTO SUTURE SPINAL NERVE HOOK | United States Surgical, A Division of Tyco Healthc | 1994-07-20 | 30 | 0 |
| K923723 | SILICONE BRAIN SPATULA SET | Redmond Neurosurgical, Inc. | 1992-08-12 | 16 | 0 |
| K910225 | BONE PAD REMOVER | Acra Cut, Inc. | 1991-02-12 | 25 | 0 |
| K910226 | DURAL DISSECTORS | Acra Cut, Inc. | 1991-02-12 | 25 | 0 |
| K902850 | ZEPPELIN INSTRUMENTS | Ruggles Corp. | 1990-07-18 | 19 | 0 |
| K892546 | TAYLOR SPINAL RETRACTOR | Zinnanti Surgical Instruments, Inc. | 1989-05-11 | 30 | 0 |
| K882422 | DISPOSABLE ARACHNOID KNIFE | Microbio-Medics, Inc. | 1988-09-06 | 85 | 0 |
| K880278 | MALLEABLE PTFE COATED BRAIN SPATULAE | Downs Surgical , Ltd. | 1988-02-11 | 20 | 0 |
| K874962 | FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS | Solway, Inc. | 1988-02-02 | 62 | 0 |
| K874630 | RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS | Downs Surgical , Ltd. | 1987-12-23 | 43 | 0 |
| K863416 | RAYLOR MINI-PROBE | Cedar Surgical, Inc. | 1986-09-24 | 21 | 0 |
| K863415 | RAYLOR BONE IMPACTORS | Cedar Surgical, Inc. | 1986-09-24 | 21 | 0 |
| K862331 | FUJITSU MALLEABLE - TIP BRAIN SPATULA | Downs Surgical , Ltd. | 1986-07-01 | 12 | 0 |
| K861630 | NEUROSURGICAL INSTURMENTS (VARIOUS) | Downs Surgical , Ltd. | 1986-05-09 | 10 | 0 |
| K832343 | DERMALAND DURAL HOOKS | National Fabtronix, Inc. | 1983-08-12 | 25 | 0 |
| K822048 | H-H NERVE ROOT RETRACTOR | Holter-Hausner Intl. | 1982-07-22 | 10 | 0 |
| K821357 | MODIFIED NEURO SURGERY NIBBLING FORCEPS | Downs Surgical , Ltd. | 1982-05-14 | 8 | 0 |
| K802726 | INSTRUMENTS NONSTERILE & STERILE | Ascep, Inc. | 1980-11-19 | 23 | 0 |
| K801760 | FIELD-LEE BRAIN BIOPSY NEEDLE | American V. Mueller | 1980-09-09 | 43 | 0 |
| K780579 | SUBCUPASS TUNNELING TOOL | Medtronic Vascular | 1978-05-19 | 39 | 0 |
| K780520 | VAS APPROXIMATOR | Edward Weck, Inc. | 1978-05-16 | 46 | 0 |
| K772371 | BAYONET SURGICAL INSTRUMENTS | Edward Weck, Inc. | 1978-01-06 | 10 | 0 |
| K772389 | DANDY HEMOSTATIC FORCEPS | Edward Weck, Inc. | 1978-01-06 | 10 | 0 |
| K772013 | PERCUPASS TUNNELING TOOL MODEL 3452 | Medtronic Vascular | 1977-10-28 | 3 | 0 |
| K761095 | VANDERBILT CURETTE | Codman & Shurtleff, Inc. | 1976-11-30 | 8 | 0 |
| K761097 | VANDERBILT BLADE HOLDER | Codman & Shurtleff, Inc. | 1976-11-30 | 8 | 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