Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Transidyne General Corp. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
206 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961217 | BODILY FLUID DISPOSAL KIT | Transidyne General Corp. | 1996-07-25 | 119 | 0 |
| K955658 | LACERATION TRAY | Transidyne General Corp. | 1996-01-25 | 44 | 0 |
| K950743 | ORAL PROCEDURE PACK | Transidyne General Corp. | 1995-03-31 | 42 | 0 |
| K950773 | PROPHYLAXIS PACK | Transidyne General Corp. | 1995-03-31 | 38 | 0 |
| K950449 | SURGICAL BUR | Transidyne General Corp. | 1995-03-01 | 26 | 0 |
| K950403 | SURGICAL SAW BLADES | Transidyne General Corp. | 1995-02-21 | 21 | 0 |
| K924811 | I.V. START KIT | Transidyne General Corp. | 1993-06-17 | 265 | 0 |
| K924243 | TRACHEOSTOMY CARE KIT | Transidyne General Corp. | 1993-06-16 | 296 | 0 |
| K922339 | SUTURE REMOVAL KIT | Transidyne General Corp. | 1992-12-11 | 206 | 0 |
| K922041 | PRIMARY SURGICAL DRESSING TRAY | Transidyne General Corp. | 1992-11-06 | 189 | 0 |
| K897133 | MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT | Transidyne General Corp. | 1990-03-30 | 93 | 0 |
| K896373 | 1400 SERIES EVIDENCE COLLECTION KIT | Transidyne General Corp. | 1990-02-26 | 112 | 0 |
| K895202 | 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT | Transidyne General Corp. | 1989-09-15 | 28 | 0 |
| K891388 | 1570 - FETAL BLOOD SAMPLING KIT | Transidyne General Corp. | 1989-03-28 | 14 | 0 |
| K831459 | FETAL BLOOD SAMPLING KIT #1560 | Transidyne General Corp. | 1983-06-30 | 55 | 0 |
| K812601 | SQC BUFFER | Transidyne General Corp. | 1981-10-02 | 18 | 0 |
| K812552 | COROMETRICS MEDICAL SYST. 220 PH ANALY. | Transidyne General Corp. | 1981-09-23 | 19 | 0 |
| K810028 | FETAL BLOOD SAMPLING KIT MODEL 1560 | Transidyne General Corp. | 1981-01-16 | 10 | 0 |
| K803240 | CORNING 760 FLUOROMETER/DENSITOMETER | Transidyne General Corp. | 1981-01-09 | 17 | 0 |
| K800271 | COROMETRICS MEDICAL SYSTEMS 220 PH SYS. | Transidyne General Corp. | 1980-02-26 | 20 | 0 |
| K780318 | MODULAR SCANNING DENSITOMETER SYS. | Transidyne General Corp. | 1978-04-12 | 47 | 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