Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GET — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
178 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960473 | AESCULAP POWER SYSTEM HANDPIECE | Aesculap, Inc. | 1996-03-07 | 35 | 0 |
| K955174 | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOM | Sodem Diffusion SA | 1996-01-22 | 70 | 0 |
| K942987 | NUCLEOTOME L KIT | Surgical Dynamics, Inc. | 1995-10-30 | 497 | 0 |
| K954076 | MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS | Midas Rex Pneumatic Tools, Inc. | 1995-10-18 | 49 | 0 |
| K953433 | MIDAS REX TELESCOPING SYSTEM | Midas Rex Pneumatic Tools, Inc. | 1995-09-15 | 56 | 2 |
| K953432 | ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING | Midas Rex Pneumatic Tools, Inc. | 1995-09-14 | 55 | 1 |
| K952463 | GS & GS20 SURGICAL TOOL SYSTEM | Midas Rex Pneumatic Tools, Inc. | 1995-07-17 | 52 | 1 |
| K952300 | MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) | Midas Rex Pneumatic Tools, Inc. | 1995-05-26 | 10 | 0 |
| K914753 | AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | 1992-06-11 | 233 | 0 |
| K910071 | PORTA GAS COMPRESSED GAS CYLINDER CART | Sen Tech Medical Corp. | 1991-03-22 | 72 | 0 |
| K904578 | MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | 1990-10-30 | 28 | 0 |
| K885066 | HEMATOME SYSTEM | Surgical Dynamics, Inc. | 1989-05-01 | 146 | 0 |
| K872951 | AMERICAN BRAIN RETRACTOR COVER | American Silk Sutures, Inc. | 1987-09-16 | 50 | 0 |
| K863447 | STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II | Stryker Corp. | 1986-09-29 | 21 | 0 |
| K843498 | BIPOLAR SUCTION ELECTRODE | Eder Instrument Co, Inc. | 1984-12-14 | 99 | 0 |
| K840370 | SURG-A-STAT VASECTOMY TIP | Suncoast Medical Manufacturers, Inc. | 1984-07-23 | 178 | 0 |
| K833187 | HALL OSTEON | Amsco Co. | 1983-10-31 | 42 | 0 |
| K832186 | HALL DRILL/REAMER | Amsco Co. | 1983-08-12 | 37 | 0 |
| K832188 | HALL RECIPROCATOR | Amsco Co. | 1983-08-12 | 37 | 0 |
| K832187 | HALL OSCILLATOR | Amsco Co. | 1983-08-12 | 37 | 0 |
| K831675 | TWIST LOCK DRILL 1120 | Micro-Aire Surgical Instruments, Inc. | 1983-06-30 | 38 | 0 |
| K800382 | CLEAR-VIEW MIRROR WARMER | Surgical Mechanical Research, Inc. | 1980-05-14 | 82 | 0 |
| K790195 | FOOT VALVE | American Safety | 1979-02-26 | 33 | 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