Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ultracell Medical Technologies, Inc. · Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
232 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012196 | ULTRACELL ABSORBENT STICK | Ultracell Medical Technologies, Inc. | 2001-08-24 | 42 | 0 |
| K972634 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-12-17 | 156 | 0 |
| K972633 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-12-17 | 156 | 0 |
| K973083 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | 1997-12-09 | 113 | 0 |
| K973558 | VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) | Ultracell Medical Technologies, Inc. | 1997-11-24 | 66 | 0 |
| K973085 | ULTRACELL PACKING WITH SLEEVE | Ultracell Medical Technologies, Inc. | 1997-11-18 | 92 | 0 |
| K972635 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-10-01 | 79 | 0 |
| K970328 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | 1997-04-21 | 84 | 0 |
| K950647 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | 1995-08-15 | 183 | 0 |
| K950372 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | 1995-04-17 | 76 | 0 |
| K950370 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | 1995-04-17 | 76 | 0 |
| K950373 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | 1995-04-17 | 76 | 0 |
| K950659 | ULTRACELL RETRACTOR COVERS | Ultracell Medical Technologies, Inc. | 1995-04-13 | 59 | 0 |
| K945554 | EPISTAXIS BALLOON CATHETER WITH PACKING | Ultracell Medical Technologies, Inc. | 1995-02-17 | 95 | 0 |
| K945555 | NASAL SPLINT | Ultracell Medical Technologies, Inc. | 1995-01-19 | 66 | 0 |
| K945556 | ANTERIOR/POSTERIOR EPISTAXIS CATHETER | Ultracell Medical Technologies, Inc. | 1995-01-18 | 65 | 0 |
| K923922 | SURGICAL SPEARS | Ultracell Medical Technologies, Inc. | 1993-03-19 | 226 | 3 |
| K924542 | NASAL-SINUS PACKING | Ultracell Medical Technologies, Inc. | 1993-02-12 | 157 | 0 |
| K920357 | ULTRACELL EAR WICK | Ultracell Medical Technologies, Inc. | 1993-02-01 | 371 | 6 |
| K920358 | ULTRACELL NASAL PACKING | Ultracell Medical Technologies, Inc. | 1992-11-30 | 308 | 3 |
| K920353 | ULTRACELL INSTRUMENT WIPE | Ultracell Medical Technologies, Inc. | 1992-09-15 | 232 | 0 |
| K920356 | SURGICAL SPONGES | Ultracell Medical Technologies, Inc. | 1992-08-06 | 192 | 0 |
| K920355 | SPECIALTY SPONGES | Ultracell Medical Technologies, Inc. | 1992-08-06 | 192 | 0 |
| K920354 | OPHTHALMIC SPONGES | Ultracell Medical Technologies, Inc. | 1992-08-05 | 191 | 1 |
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